Australian Regulatory Guidelines for
Complementary Medicines
Part IV: General Guidance
Version 4.2, August 2011
Therapeutic Goods Administration
About the Therapeutic Goods Administration (TGA)

The TGA is a division of the Australian Government Department of Health and Ageing, and is
responsible for regulating medicines and medical devices.

The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management
approach designed to ensure therapeutic goods supplied in Australia meet acceptable
standards of quality, safety and efficacy (performance), when necessary.

The work of the TGA is based on applying scientific and clinical expertise to decision-making, to
ensure that the benefits to consumers outweigh any risks associated with the use of medicines
and medical devices.

The TGA relies on the public, healthcare professionals and industry to report problems with
medicines or medical devices. The TGA investigates reports received by it to determine any
necessary regulatory action.

To report a problem with a medicine or medical device, please see the information on the TGA
website.
Copyright
© Commonwealth of Australia 2011
This work is copyright. Apart from any use as permitted under the Copyright Act 1968, no part may be reproduced by any
process without prior written permission from the Commonwealth. Requests and inquiries concerning reproduction and rights
should be addressed to the Commonwealth Copyright Administration, Attorney General’s Department, National Circuit, Barton
ACT 2600 or posted at http://www.ag.gov.au/cca
Australian Regulatory Guidelines for Complementary Medicines, Part IV
V4.2 August 2011
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Therapeutic Goods Administration
Version history
Version
Description of change
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Effective date
V4.0
The ARGCM was amended to take
into account the TGA restructure of
July 2010. Some editorial changes
were made, such as corrections of
typographic errors.
Office of Complementary
Medicines
March 2011
V4.1
Version 4.0 was transferred into
the new TGA template. The content
remained the same, but page
numbers changed. This version
was also labelled ‘Version 4.0’
Office of Parliamentary and
Strategic Support
May 2011
V4.2
A version history table was added.
The version was labelled as
‘Version 4.2’. Changes were also
made to capitalisation of titles.
Office of Parliamentary and
Strategic Support
August 2011
Australian Regulatory Guidelines for Complementary Medicines, Part IV
V4.2 August 2011
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Therapeutic Goods Administration
Contents
1.
Overview
2.
Homoeopathic preparations and mother tinctures 10
2.1.
4.
5.
Notes on homoeopathic preparations ___________________________ 10
2.1.1.
Homoeopathic potency_______________________________________________________ 10
2.1.2.
What is a Listable homoeopathic preparation? _____________________________ 11
2.1.3.
Which homoeopathic preparations do not need to be included in the ARTG?11
2.1.4.
Specific labelling requirements for homoeopathic preparations __________ 11
2.1.5.
Guidance on claims ___________________________________________________________ 11
2.1.6.
Poisons scheduling ___________________________________________________________ 11
2.1.7.
Manufacture __________________________________________________________________ 12
2.2.
3.
9
Criteria for Listing__________________________________________________ 12
Traditional herbal medicines
13
3.1.
Traditional use _____________________________________________________ 14
3.2.
Quality _______________________________________________________________ 14
3.3.
Stability testing _____________________________________________________ 15
3.4.
Safety _________________________________________________________________ 15
3.5.
Efficacy _______________________________________________________________ 16
3.6.
Multi-ingredient products ________________________________________ 16
3.7.
Supporting material _______________________________________________ 17
Aromatherapy
18
4.1.
Essential oil products making therapeutic claims_____________ 18
4.2.
Essential oils for use as starting materials _____________________ 19
4.2.1.
Essential oils supplied solely as starting materials to practitioners_______ 19
4.2.2.
Essential oils used in the manufacture of therapeutic goods ______________ 19
Practitioner products
20
5.1.
Dispensed and extemporaneously compounded medicines _ 20
5.2.
Pre-packaged (manufactured) medicines ______________________ 20
5.3.
‘For Practitioner Dispensing Only’ products ___________________ 21
5.3.1.
Purpose statements on ‘For Practitioner Dispensing Only’ product labels 21
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Therapeutic Goods Administration
5.4.
6.
7.
Legal constraints ___________________________________________________ 22
Exempt / Excluded goods
23
6.1.
Excluded _____________________________________________________________ 23
6.2.
Exempt _______________________________________________________________ 23
6.3.
Further information _______________________________________________ 23
Proprietary ingredients
24
7.1. New classification system for proprietary ingredients lodged
with the TGA for use in Listed medicines ______________________________ 24
7.2.
Data requirements for proprietary ingredients _______________ 25
7.3. Specific requirements for proprietary ingredients in Listed
medicines ___________________________________________________________________ 25
7.3.1.
Type 1a: Colours ______________________________________________________________ 25
7.3.2.
Type 1b: Flavours, fragrances and inks _____________________________________ 25
7.3.3.
Type 2: Active intermediate formulations (active pre-mixes) _____________ 26
7.3.4.
Type 3: Vehicles (cream and ointment bases, capsule shells) _____________ 26
7.3.5.
Type 4: Pre-formulated mixes of preservatives ____________________________ 26
7.4.
8.
Labelling associated with proprietary ingredients ___________ 27
Interface issues
8.1.
Medicine / Device interface _______________________________________ 28
8.1.1.
8.2.
28
Regulatory system for medical devices _____________________________________ 28
Cosmetic / Medicine interface ____________________________________ 29
8.2.1.
Composition __________________________________________________________________ 29
8.2.2.
Proposed use__________________________________________________________________ 29
8.2.3.
Legislation ____________________________________________________________________ 30
8.3.
Medicine / Food interface _________________________________________ 30
8.3.1.
Food Standards Australia New Zealand (FSANZ) ___________________________ 30
8.3.2.
Differentiation between therapeutic goods and foods _____________________ 31
8.3.3.
Food / Medicines interface group ___________________________________________ 32
8.4. Complementary / Pharmaceutical medicine interface: route of
evaluation ___________________________________________________________________ 33
8.4.1.
OCM to OTC or vice versa _____________________________________________________ 33
8.4.2.
Prescription to OTC or OCM _________________________________________________ 33
8.4.3.
OCM to Prescription __________________________________________________________ 34
8.4.4.
Excipients _____________________________________________________________________ 34
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8.4.5.
Currently registered non-prescription transdermal patches ______________ 34
8.4.6.
Administrative details ________________________________________________________ 35
9. Australian native and endangered species in
therapeutic goods
36
9.1.
Background _________________________________________________________ 36
9.2.
The role of the Therapeutic Goods Administration ___________ 37
9.3.
More information __________________________________________________ 37
10.
Other legislation
38
11.
Certificates of analysis – product
39
12.
Product Specifications
40
13.
Enforcement procedures
42
14.
15.
13.1.
Listed medicines _________________________________________________ 42
13.2.
Post market monitoring ________________________________________ 42
13.3.
Listing Compliance Section (LCS) of the OCM ________________ 43
13.4.
Regulatory action ________________________________________________ 43
Review of decisions
44
14.1.
Appeal mechanisms (Section 60 appeals) ____________________ 44
14.2.
The Administrative Appeals Tribunal (AAT) ________________ 45
14.3.
Federal Court _____________________________________________________ 45
Genetically Modified Organisms
46
15.1.
Definitions ________________________________________________________ 46
15.2.
TGA assessment of GMOs and GM Products __________________ 46
15.3.
Gene technology legislation ____________________________________ 47
15.3.1. Public record _________________________________________________________________ 47
15.3.2. Exchange of advice on GMOs or GM products ______________________________ 48
16.
15.4.
Labelling __________________________________________________________ 48
15.5.
More information ________________________________________________ 49
Medicines for export
50
16.1.
Medicines already approved for supply in Australia _______ 50
16.2.
‘Solely for Export’ medicines ___________________________________ 50
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Therapeutic Goods Administration
17.
Naming of new substances and terminology
52
17.1.
What is Australian approved terminology? __________________ 52
17.2.
What are the different types of names for substances? ____ 53
17.3.
Substances that do not have an approved name ____________ 54
17.3.1. Application Forms ___________________________________________________________ 54
17.3.2. Review of New AAN Requests ______________________________________________ 55
18.
Colourings permitted in medicines for oral use 57
19.
Herbal ingredients – quality
58
19.1.
Background _______________________________________________________ 58
19.2.
Scope of the Guideline for herbal substances ________________ 58
19.3.
General concepts _________________________________________________ 59
19.3.1. Characterisation _____________________________________________________________ 59
19.3.2. Development considerations _______________________________________________ 59
19.3.3. Pharmacopoeial tests and acceptance criteria _____________________________ 60
19.3.4. Alternative non-pharmacopoeial tests _____________________________________ 60
19.3.5. Evolving technologies _______________________________________________________ 60
19.3.6. Reference standard __________________________________________________________ 60
19.3.7. Statistical concepts __________________________________________________________ 60
19.4.
Compositional guideline ________________________________________ 60
19.4.1. Definition of compositional guideline ______________________________________ 60
19.4.2. Justification of specifications________________________________________________ 61
19.4.3. Universal tests / criteria ____________________________________________________ 61
19.5.
20.
Herbal preparations _____________________________________________ 63
Ingredients of human or animal origin
66
20.1. Minimising the risk of transmitting animal spongiform
encephalopathy agents via human and veterinary medicinal
products _____________________________________________________________________ 66
20.2.
Ingredients of human origin ___________________________________ 67
21.
Glossary of terms used in the Australian
Regulatory Guidelines for Complementary Medicines 68
21.1.
Notes _______________________________________________________________ 68
21.2.
Glossary ___________________________________________________________ 68
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Therapeutic Goods Administration
22.
Abbreviations and acronyms used in the
Australian Regulatory Guidelines for Complementary
Medicines
93
23.
Hyperlink references contained in the Australian
Regulatory Guidelines for Complementary Medicines 98
23.1.
Therapeutic Goods Act 1989 ___________________________________ 99
23.2.
Therapeutic Goods Regulations 1990_________________________ 99
23.3.
TGA guidance _____________________________________________________ 99
23.4.
Other guidance __________________________________________________ 101
23.5.
Forms _____________________________________________________________ 102
23.6.
Therapeutic Goods Orders ____________________________________ 103
23.7.
Other legislation ________________________________________________ 103
23.8.
E-mail contacts __________________________________________________ 104
23.9 Other regulatory agencies _________________________________________ 104
23.10. Miscellaneous ___________________________________________________ 104
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1. Overview
The purpose of this Part of the Guidelines is to provide guidance to sponsors on specific
complementary medicine modalities such as homoeopathy, traditional herbal medicine and
aromatherapy. This part also provides information on exempt medicines, combination
complementary / pharmaceutical medicines and the food / medicine interface.
The regulatory requirements for the Registration and Listing of complementary medicines are
discussed in Parts I and II of the Guidelines. The regulatory requirements for the evaluation of
complementary medicine substances are discussed in Part III.
Detailed guidance is provided in the following sections:
Section 2. –
Homoeopathic Preparations and Mother Tinctures
Section 3. –
Traditional Herbal Medicines
Section 4. –
Aromatherapy
Section 5. –
Practitioner Products
Section 6. –
Exempt / Excluded Goods
Section 7. –
Proprietary Ingredients
Section 8. –
Interface Issues
Section 9. –
Australian Native and Endangered Species in Therapeutic Goods
Section 10. –
Other Legislation
Section 11. –
Certificates of Analysis – Product
Section 12. –
Product Specifications
Section 13. –
Enforcement Procedures
Section 14. –
Review of Decisions
Section 15. –
Genetically Modified Organisms
Section 16. –
Medicines for Export
Section 17. –
Naming of New Substances and Terminology
Section 18. –
Colourings Permitted in Medicines for Oral Use
Section 19. –
Herbal Ingredients - Quality
Section 20. –
Ingredients of Human or Animal Origin
Section 21. –
Glossary of Terms Used in the ARGCM
Section 22. –
Abbreviations and Acronyms Used in the ARGCM
Section 23. –
Hyperlink References Contained in the ARGCM.
Australian Regulatory Guidelines for Complementary Medicines,
Part IV, Section 1 - Overview
V4.2 August 2011
Page 9 of 106
2. Homoeopathic
preparations and mother
tinctures
This section is divided into the following subsections:
2.1.
Notes on homoeopathic preparations
2.2.
Criteria for Listing
In Australia, products containing homoeopathic medicines are regulated under the Therapeutic
Goods Act 1989 (the Act). Homoeopathic medicines are considered to be low-risk medicines. Where
a homoeopathic preparation meets certain conditions it may not need to be included in the
Australian Register for Therapeutic Goods (ARTG) and, in some cases, may not need to be
manufactured under good manufacturing practice (GMP).
The current definition for ‘homoeopathic preparation’ included in the Therapeutic Goods
Regulations 1990 (the Regulations) is based upon the central tenet of homoeopathy – similia
similibus curentur or ‘let like cure like’, and the principles of homoeopathic pharmacy – serial
dilution and succussion of a stock.
Consistent with the definition, the dilution of an ingredient does not make it a homoeopathic
preparation. A homoeopathic preparation must also be ‘formulated for use on the principle that it is
capable of producing in a healthy person symptoms similar to those which it is administered to
alleviate’; in other words, it should comply with the principle of ‘like cures like’.
A homoeopathic medicine should be adequately described to ensure that it is clearly differentiated
from those medicines not consistent with the homoeopathic paradigm.
2.1. Notes on homoeopathic preparations
2.1.1. Homoeopathic potency
Homoeopathic potency is defined in Therapeutic Goods Order No. 69 – General Requirements for
Labels for Medicines (TGO 69):
Homoeopathic potency means the dilution factor expressed as:
a.
‘nX’, where each dilution is a decimal or ten fold dilution and ‘n’ is the number of dilutions such
that the total dilution is 10n; or
b.
‘nC’, where each dilution is a centesimal or hundred fold dilution and ‘n’ is the number of
dilutions such that the total dilution is 100n.
Australian Regulatory Guidelines for Complementary Medicines, Part IV,
Section 2 – Homoeopathic preparations and mother tinctures
V4.2 August 2011
Page 10 of 106
2.1.2. What is a Listable homoeopathic preparation?
To be Listed as a homoeopathic preparation, a product must be a ‘homoeopathic preparation’ as
defined in Regulation 2 of the Therapeutic Goods Regulations 1990 (the Regulations); i.e. it must be
a preparation:

formulated for use on the principle that it is capable of producing in a healthy person
symptoms similar to those which it is administered to alleviate;

prepared according to the practices of homoeopathic pharmacy using the methods of:
– serial dilution and succussion of a mother tincture in water, ethanol, aqueous ethanol or
glycerol; OR
– serial trituration in lactose.
2.1.3. Which homoeopathic preparations do not need to be included in the ARTG?
Where an ingredient meets the definition of ‘homoeopathic preparation’, and meets the conditions
set out under Schedule 5, Item 8 of the Regulations, it may not need to be included in the ARTG.
This does not apply where the homoeopathic preparation is part of a product containing other
ingredients requiring inclusion in the ARTG.
Homoeopathic preparations are exempt from the need to be Listed or Registered if:

all components are more dilute than a one-thousand-fold dilution of the mother tincture;
the indications for use are permitted indications under clause 4 of the Therapeutic Goods
Advertising Code (TGAC);

the product is not of a kind that needs to be sterile; and / or
the preparation contains no ingredients of human origin, or animal-sourced material which is a
Category A or Category B substance (see ARGCM Part V –Minimising the Risk of Transmissible
Spongiform Encephalopathies (TSEs)).
Homoeopathic medicines prepared by practitioners specifically for an individual patient do not
need to be entered in the ARTG.
2.1.4. Specific labelling requirements for homoeopathic preparations
The labelling standard, Therapeutic Goods Order No. 69 – General Requirements for Labels for
Medicines (TGO 69) includes some special requirements for homoeopathic preparations.
2.1.5. Guidance on claims
The presence of claimed indications for use that are outside those permitted in Clause 4 of the
TGAC does not make a homoeopathic preparation Registrable; it may still be Listed in the ARTG.
However, the label on the container and on the primary pack of such products must include a
statement that the indications have not been ‘approved’ by the TGA. Such a statement would be:
‘Homoeopathic product without approved therapeutic indications’.
The TGAC requirements apply in the usual way to homoeopathic products, which may not be
displayed and advertised to the general public for purposes outside those permitted by the TGAC
and Regulations, whether or not those indications are Listed in the ARTG.
2.1.6. Poisons scheduling
Some homoeopathic preparations prepared from scheduled poisons are exempted from the
requirements of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) by the
provisions of SUSMP Appendix G, which covers products containing certain poisons at very low
(specified) concentrations.
Australian Regulatory Guidelines for Complementary Medicines, Part IV,
Section 2 – Homoeopathic preparations and mother tinctures
V4.2 August 2011
Page 11 of 106
Appendix C of the SUSMP lists hazardous substances that are generally prohibited as product
ingredients. However, it is accepted that this prohibition does not apply to homoeopathic
preparations in which the ingredient is a dilution of 1012 or greater of the mother tincture.
2.1.7. Manufacture
Concentrated homoeopathic preparations (less than or equal to a one-thousand-fold dilution of the
mother tincture) must be manufactured by a licensed manufacturer. Those more dilute than a onethousand-fold dilution of the mother tincture are exempt from this requirement provided they are
not preparations of a kind required to be sterile.
If imported products are of a type whose manufacturer in Australia would need to be licensed,
evidence of an acceptable standard of overseas manufacture must be provided and cleared before
lodgement of the Listing application. An explanation of how this evidence can be obtained is given
in the document Guidelines on Standard of Overseas Manufacturers.
2.2. Criteria for Listing
Homoeopathic preparations and mother tinctures are Listable if they:

are a mother tincture or a homoeopathic dilution of one-thousand-fold or less; OR (irrespective
of potency) have indications for use outside those permitted for public advertising under
Clause 4 of the TGAC, or are derived from substances of human origin or animal-sourced
material that are Category A or Category B substances;

contain an ingredient which is at a dilution of one-thousand-fold or less (of the mother
tincture) and any part of the manufacture occurring in Australia is carried out by a licensed
manufacturer;

contain an ingredient which is at a dilution of one-thousand-fold or less (of the mother
tincture), and are manufactured overseas, and evidence has been provided to demonstrate that
the overseas manufacture is of a standard equivalent to that required in Australia;

are NOT subject to the conditions of a schedule (or applicable Appendix) to the SUSMP, OR if
the product is subject to the conditions of a schedule (or applicable Appendix) to the SUSMP,
the ingredient that causes the product to be scheduled is present at a dilution greater than onethousand-fold;

do NOT contain substances that are prohibited imports under the Customs Act 1901 [refer
Customs (Prohibited Imports) Regulations];

are NOT for supply as a pharmaceutical benefit under the Pharmaceutical Benefits Scheme
(PBS); and

are NOT a preparation of a kind that needs to be sterile (such as eye drops, eye ointments,
injections, irrigation solutions and implants).
Listed homoeopathic preparations and mother tinctures which are Listed must:

be labelled in compliance with the general requirements for labels for medicinal products as
current and in force (currently TGO 69 and 69C) , and any other applicable official standards;

comply with advertising requirements set out in Schedule 2 of the Regulations; and

comply with any quality or safety criteria prescribed in the Regulations.
Australian Regulatory Guidelines for Complementary Medicines, Part IV,
Section 2 – Homoeopathic preparations and mother tinctures
V4.2 August 2011
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3. Traditional herbal
medicines
This section is divided into the following subsections:
3.1.
Traditional use
3.2.
Quality
3.3.
Stability testing
3.4.
Safety
3.5.
Efficacy
3.6.
Multi-ingredient products
3.7.
Supporting material
herbal substance means all or part of a plant or substance (other than a pure chemical or a
substance of bacterial origin):
a.
that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing
with an inert diluent substance or another herbal substance or mixing with water, ethanol,
glycerol or aqueous ethanol; and
b.
that is not subjected to any other treatment or process other than a treatment or process that is
necessary for its presentation in a pharmaceutical form.
Herbal medicines are those therapeutic goods which are, or contain as the major active ingredient(s),
herbal substances as defined in Regulation 2 – Interpretation of the Therapeutic Goods Regulations
1990 (the Regulations).
The following guidance is intended to provide assistance for sponsors preparing
Registration applications for traditional herbal medicines.
An ‘ingredient’ refers to a herbal substance in the formulation, and a ‘component’ is a chemical
constituent of an ingredient.
There are special characteristics of herbal products which necessitate the provision of additional
information for their Registration for therapeutic use. This does not imply that the principles of
evaluation differ but that allowance is made for different product characteristics which include
that:

usage is wholly or partly based on a traditional use rather than efficacy established by formal
clinical studies;
Australian Regulatory Guidelines for Complementary Medicines,
Part IV, Section 3 – Traditional herbal medicines
V4.2 August 2011
Page 13 of 106

active components of the herbs may not have been isolated, characterised or quantified; and

efficacy is claimed to result from the summation of pharmacological activity of an undefined
blend of active components from one or more species of herb.
3.1. Traditional use
A ‘traditional medical system’ means a formalised set of practices, historically evolved from
deliberate behaviour to enhance health and not explicitly derived from the conceptual framework
of modern medicine.
A ‘traditional use’ means the use of a herb or herbal mixture by practitioners of a traditional
medical system where:

the use is well established and widely acknowledged, i.e. the use represents the accumulated
experience of many practitioners over an extended period;

the effective preparation, dosage, method of use and indications are well established; and

the botanical identity of the herbal substance(s) is clearly established.
This subsection of the Guidelines does not apply directly to traditional medicines with
ingredients of animal and mineral origin. However, many of the same principles do
apply, and sponsors of such products are advised to follow these guidelines wherever
possible.
This subsection does not apply to active component(s) of a herb which have been
identified and either isolated or synthesised as chemical component(s) of a medicine
(e.g. atropine).
3.2. Quality
Each herbal ingredient in the formulation should be characterised by giving its Australian
Approved Name (AAN) (refer to Section 3 Herbal Substances in the Therapeutic Goods
Administration (TGA) Approved Terminology for Medicines). Sponsors should ensure that they
state the part of the plant used and its form, i.e. whether it is a fresh or dried material, together with
details of any processing it undergoes before use in the manufacture of the product. Where
appropriate it may be necessary to state the country or region of origin of the ingredient, or give
other details such as time of harvesting and stage of growth, which are pertinent to the quality of
the ingredient.
If a herb is not included in the Herbal Substances AAN List, you should propose a botanical name
for it, using the application form included in the introduction to the List.
Australian Regulatory Guidelines for Complementary Medicines,
Part IV, Section 3 – Traditional herbal medicines
V4.2 August 2011
Page 14 of 106
If the herb is processed to produce a galenical form, the extraction and any concentration processes
should be described or a reference cited, indicating whether the extract or additives, such as
calcium phosphate in dry extracts, are present in the final product formulation.
Starting material specifications should be provided or a reference cited for each starting material.
Where a pharmacopoeial reference does not apply to an ingredient, the specification should give
details of the test methods and test specifications. Appropriate testing techniques are required in
accordance with the Guide to Good Manufacturing Practice for Medicinal Product - Annexes, Annex 7
– Manufacture of Herbal Medicinal Products. These would need to cover identity and, where
appropriate, adulteration and contamination, both chemical and microbiological. Where a herbal
ingredient is standardised in terms of a component(s) and the statement of activity on the label is
based on this standardisation, you should provide evidence of how the standardisation is achieved.
Data on the nature or chemistry of the active component should be provided. This may include
citation of pharmacopoeial monographs, photocopies from authoritative references, or your own
data.
A brief description of the manufacturing process should also be provided.
The finished product specifications should be provided, defining the physical, chemical and
microbiological characteristics of the product and detailing quality-control test methods and test
specifications.
3.3. Stability testing
Refer to ARGCM Part I, and ARGCM Part I, Appendix 3 – Stability of the Finished Product for detailed
information on stability testing. In addition, further advice for sponsors is provided in the
document Questions & Answers on the Stability Testing of Listed Complementary Medicines, which is
published on the TGA website at <http://www.tga.gov.au/industry/cm-stability-testing-qa.htm>.
Where the active components of a traditional medicine cannot be quantified, you should state the
basis for establishing the shelf life, taking into account the physical and microbiological stability of
the product and its chemical stability based on chromatographic profile. Physical characteristics
could include colour or odour changes, and precipitation.
3.4. Safety
Traditional use is not a substitute for safety assessment. As herbal components are isolated and
studied, and as the methodology of toxicological studies improves, much more information on the
safety of herbs is becoming available. However, long-term and safe therapeutic use of a herb or
formula will be taken into account in evaluating the safety of a product.
Safety is dependent upon the formulation of the product overall, its intended therapeutic purpose,
dosage, method (or route) of administration, duration of use, the patient group (such as children,
the elderly, and pregnant and lactating women) and use under circumstances where it may
interfere with critical medication. It is important where traditional use or a history of use is being
used to support safety, that the details of use (e.g. duration, dose etc.) be consistent with the
proposed use.
The applicant should provide details of any toxicological studies and traditional records of harmful
effects that are reasonably available to establish the safety profile of the herbal ingredients and the
product formulation. Details should be provided where the product is contraindicated for use in
particular patient groups.
Australian Regulatory Guidelines for Complementary Medicines,
Part IV, Section 3 – Traditional herbal medicines
V4.2 August 2011
Page 15 of 106
Information on the pharmacological activity of ingredients and their components should be
provided where available.
Where the data documenting a tradition of use is insufficient, or there are suspicions of effects that
are difficult or impossible to detect with population or clinical studies, the safety evaluation (unless
otherwise justified) will need to be supported with other studies (e.g. by single and repeat-dose
toxicity, immunotoxicity, reproduction, genotoxicity and carcinogenicity studies).
3.5. Efficacy
Traditional use will be taken into account in establishing efficacy; see the guidance document
Guidelines for Levels and Kinds of Evidence to Support Indications and Claims Levels of Evidence.
Supporting evidence can constitute or include material from suitable herbal reference books,
provided that the information has not been superseded by more recent research and study. In
many instances, the documentation associated with traditional use may not be sufficient in itself to
support efficacy for Registration purposes. Such data would need to be supplemented with clinical
evidence of efficacy.
Where claims for a herb, prepared with a non-traditional method of harvesting and / or processing,
are based on the traditional use of that herb, evidence should be provided to establish that the
preparations are medicinally equivalent. If the preparations are medicinally equivalent, clinical
evidence of the efficacy of the ‘new’ preparation may not be required.
Preparations would be considered ‘medicinally equivalent’ if the preparations, when used in the
recommended doses, have or would be reasonably likely to have, a comparable therapeutic effect
on the body.
To establish this, it should be shown that the preparations contain a similar range and
concentration of constituents, including any known active constituents.
For non-traditional use of herbs, therapeutic claims will need to be supported by clinical evidence
of efficacy from published or in-house, controlled clinical trials.
Where non-herbal ingredients are included in a product, a rationale for their inclusion should be
provided.
3.6. Multi-ingredient products
Many herbal products consist of a combination of herbal ingredients, with the assumption that the
ingredients contribute an undefined range and balance of pharmacologically active components to
their overall therapeutic use.
Traditional formulations will normally be accepted unless current adverse evidence exists.
New formulations will be assessed to ensure that the evidence provided in the application
demonstrates that:

each herbal ingredient and any claimed active component(s) contribute toward the intended
therapeutic purpose (see the guidance document Guidelines for Levels and Kinds of Evidence to
Support Indications and Claims Levels of Evidence)

the ingredients are chemically, pharmacologically and therapeutically compatible and are in
appropriate, effective dosages
Australian Regulatory Guidelines for Complementary Medicines,
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
no component adversely affects the safety of the product to the point where the risk / benefit
ratio is unacceptable.
The logic of the formulation in terms of the duration of effect of the active components in the body
in relation, for instance, to the dosage regime, should be considered.
The rationality of multi-ingredient products should be considered very carefully. Sponsors are
therefore advised to consider the validity and need for multi-ingredient formulations.
3.7. Supporting material
All supporting material included in the application should be presented in a form suitable for
consideration by the Office of Complementary Medicines (OCM). Where many supporting
documents are attached, a table of contents should be included. Documents should be annotated,
giving, as appropriate, full details of the author, title, publisher, place of publication, and volume
and page numbers.
Where supporting material is provided you should also provide a brief summary of each document
stating its relevance to the application.
Abbreviations that are not defined in the introduction to the Herb List, should be defined where the
abbreviation is first used.
Where supporting materials are in a language other than English, an accurate English translation
must be provided. Where a document concerns a proposed AAN, the translation into English must
be authenticated.
Sponsors should check that their application is complete. If the application is not complete or is
otherwise deficient, a final decision will be postponed until the information needed is supplied.
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4. Aromatherapy
This section is divided into the following subsections:
4.1.
Essential oil products making therapeutic claims
4.2.
Essential oils for use as starting materials
4.1. Essential oil products making therapeutic claims
Products which contain essential oils must be Listed or Registered in the Australian Register of
Therapeutic Goods (ARTG) if they are intended for therapeutic use 1 (e.g. therapeutic claims are
made about the product such as: ‘relief of pre-menstrual symptoms’ or ‘relief of sleeplessness’).
In addition to the requirements of the Therapeutic Goods Act 1989 (the Act) and the Therapeutic
Goods Regulations 1990 (the Regulations) for Listed / Registered medicines, sponsors of products
containing essential oil(s), which are considered to be therapeutic goods, 2 must also comply with
standards such as the British Pharmacopoeia (BP), the Standard for the Uniform Scheduling of
Medicines and Poisons (SUSMP), Therapeutic Goods Order No. 69 – General Requirements for Labels
for Medicines (TGO 69) and TGO 80 Child Resistant Packaging Requirements for Medicines where
required.
Many essential oils are included in schedules to the SUSMP, but they are not subject to the conditions
of that schedule:
a.
when packed in containers having a nominal capacity of 15 mL or less, fitted with a restricted
flow insert, and labelled with the warnings:
KEEP OUT OF REACH OF CHILDREN; and NOT TO BE TAKEN;
b.
when packed in containers having a nominal capacity of 25 mL or less, fitted with a restricted
flow insert and child-resistant closure, and labelled with the warnings:
KEEP OUT OF REACH OF CHILDREN; and NOT TO BE TAKEN; or
c.
in preparations containing 25 per cent or less of essential oil.
Note: Complementary medicines containing essential oils must be Registered if they:
– contain an ingredient or component that is subject to the conditions of a
Schedule (or relevant appendix) to the SUSMP; and / or
– contain an ingredient or component that has been identified as not suitable for
use in Listed medicines (see Schedule 4, Part 4, Division 1 of the Regulations);
and / or
– have indications inappropriate for Listed medicines.
1
2
Therapeutic use is defined in Chapter 1, Section 3 of the Act.
Therapeutic goods are also defined in Chapter 1, Section 3 of the Act.
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4.2. Essential oils for use as starting materials
4.2.1. Essential oils supplied solely as starting materials to practitioners
Essential oils that are supplied solely as starting materials to practitioners, are generally exempt
from the requirement to be included in the ARTG before supply. This means that these oils can be
supplied only for the purpose of being subsequently dispensed or extemporaneously compounded
for a particular person, for therapeutic application to that person.
4.2.2. Essential oils used in the manufacture of therapeutic goods
The production of essential oils that are to be used as starting materials in the manufacture of
therapeutic goods are exempt from the requirement to be manufactured under conditions of good
manufacturing practice (GMP). For example, the manufacturer of the ‘bulk’ essential oil (e.g. the
farmer extracting lavender oil from lavender plants) does not need to be licensed for GMP.
However, the manufacturer of the finished dosage form and those who undertake steps in the
manufacture (after the initial production of the oil as a starting material), such as those who are
responsible for filling, blending, labelling, release for supply, testing etc.) are currently required to
hold an appropriate GMP licence.
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5. Practitioner products
This section is divided into the following subsections:
5.1.
Dispensed and extemporaneously compounded medicines
5.2.
Pre-packaged (manufactured) medicines
5.3.
‘For Practitioner Dispensing Only’ products
5.4.
Legal constraints
5.1. Dispensed and extemporaneously compounded
medicines
Certain medicines do not need to be included in the Australian Register of Therapeutic Goods
(ARTG). This includes medicines that are dispensed, or extemporaneously compounded, for a
particular person for therapeutic application to that person. This allows complementary healthcare
practitioners, such as pharmacists, herbalists and homoeopaths, to prepare medicines for
individual patients that do not need to be assessed or evaluated by the Therapeutic Goods
Administration (TGA) for quality, safety or efficacy.
Note: The exemption applies to medicines prepared for individual patients, either
following consultations with that particular patient, or to fill a prescription for that
particular patient. The exemption does not cover situations where the practitioner
makes up medicines in advance, in anticipation of patients who may come onto the
premises and ask for that medicine.
Access to some medicinal ingredients is restricted by State and Territory drug and poisons
legislation. For example, ingredients included in Schedule 4 of the Standard for the Uniform
Scheduling of Medicines and Poisons (SUSMP) are available only on prescription from a medical
practitioner registered under a law of a State or Territory. Depending on the level of access control,
some ingredients are not available for dispensing or extemporaneous compounding by
complementary healthcare practitioners, such as herbalists, nutritionists, naturopaths,
practitioners of traditional Chinese medicine or homoeopathic practitioners.
5.2. Pre-packaged (manufactured) medicines
Most herbal ingredients are not subject to restricted access and may be used for preparing
medicines that are dispensed or extemporaneously compounded. However, some ingredients used
by practitioners in dispensing or extemporaneous compounding of medicines for patients are
subject to TGA legislation. For example, ingredients that are either pre-packaged for other
therapeutic purposes, or formulated as a dosage form (such as medicines ‘For Practitioner
Dispensing Only’ – see subsection 5.3 below), are subject to TGA assessment for quality, safety and
efficacy as appropriate, and are to be included on the ARTG.
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5.3. ‘For Practitioner Dispensing Only’ products
‘For Practitioner Dispensing Only’ products are complementary medicines that are supplied in a
dispensing pack to a (registered) complementary healthcare practitioner with the words ‘For
Practitioner Dispensing Only’ included on the label. These medicines must meet the same standards
required for other Listed or Registered complementary medicines.
The difference between ‘For Practitioner Dispensing Only’ products and other Listed or Registered
complementary medicines is that the former do not need to include a statement of their purpose on
the label. Other medicines must include therapeutic indications and claims on the label.
The regulation of complementary medicines ‘For Practitioner Dispensing Only’ is specifically
addressed in the Therapeutic Goods Order (TGO) No. 69 – General Requirements for Labels for
Medicines.
These regulatory requirements are summarised below.
TGO 69 advises that ‘complementary healthcare practitioner’ means a person described in
paragraph 4(1)(c) of the Regulations. Paragraph 4(1)(c) of the Regulations has been replaced with
Section 42AA (1)(c) of the Act, but the definition remains the same:
complementary healthcare practitioner means:
‘herbalists, homoeopathic practitioners, chiropractors, naturopaths, nutritionists, practitioners of
traditional Chinese medicine, podiatrists or osteopaths [who are] registered under a law of a State or
Territory.’
Non-registered practitioners are therefore not ‘complementary healthcare practitioners’ for the
purpose of being supplied with ‘dispensing packs’ ‘For Practitioner Dispensing Only’.
5.3.1. Purpose statements on ‘For Practitioner Dispensing Only’ product labels
Subsection (m) of Section 3(2) TGO 69 advises that, as long as goods are supplied in a dispensing
pack to a (registered) complementary healthcare practitioner and the words ‘For Practitioner
Dispensing Only’ are included on the label, the product does not require a statement of the purpose
or purposes for which it is intended that the goods be used. Other information such as an AUST L
number, as detailed in TGO 69, must be included on the label.
dispensing pack is defined in TGO69 as follows:
‘in relation to complementary healthcare, [dispensing pack] means a pack which is to be supplied
solely to complementary healthcare practitioners for supply to a person after affixing an instruction
label following a consultation with that person.’
Products available in dispensing packs and labelled ‘For Practitioner Dispensing Only’ are intended
for supply to a person after consultation with that person. An instruction label must be affixed to
the product, before supply to the person. All advisory statements appropriate for the ingredient
must be included on the label.
Note that medicinal products covered by Schedules 4 and 8 of the SUSMP, which require a
prescription before being supplied, are also exempt from the label requirement to include a
statement of the purpose for which it is intended that the product be used.
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5.4. Legal constraints
Certain diseases may be diagnosed and / or treated only by Registered medical practitioners.
Complementary healthcare practitioners should make enquiries to State and Territory Health
authorities when considering therapeutic applications for complementary medicines.
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6. Exempt / Excluded
goods
This section is divided into the following subsections:
6.1.
Excluded
6.2.
Exempt
6.3.
Further information
All medicines manufactured for supply in Australia must be Listed or Registered in the Australian
Register of Therapeutic Goods (ARTG) unless they are exempt or excluded.
6.1. Excluded
Some products may be unintentionally covered by the definition of a ‘therapeutic good’. They are
therefore specifically excluded under Section 7 of the Therapeutic Goods Act 1989 (the Act).
None of the requirements of the Act apply to excluded products.
6.2. Exempt
Some medicines do not need to be Registered or Listed in the ARTG as a result of a specific
exemption or determination. Section 18 of the Act and Schedules 5 and 5A of the Therapeutic Goods
Regulations 1990 (the Regulations) indicate the goods that are exempt from the need to be
included in the ARTG. These include, for example, medicines (other than those used for gene
therapy) that are dispensed or extemporaneously compounded for a particular person for
therapeutic application to that person; certain homoeopathic preparations; and certain shampoos
for the treatment / prevention of dandruff.
While exempt from inclusion in the ARTG, it is important to note that all other applicable
requirements under the Act and the Regulations (e.g. standards and advertising or labelling) must
be complied with.
Some medicines or persons are exempt from the manufacturing requirements set out in Part 4 of
the Act. The criteria for these exemptions are indicated in Section 34 of the Act, together with
Schedule 7 of the Regulations (exempt medicines) and Schedule 8 of the Regulations (exempt
persons). An example of a person exempt from licensing to manufacture is a pharmacist in their
place of practice (including a private hospital).
6.3. Further information
The Summary Classification of Medicines is a quick guide to whether a medicine is Listed,
Registered, exempt, or excluded. This document is available on the Therapeutic Goods
Administration (TGA) website at <http://www.tga.gov.au/industry/basics-medicinesclassification.htm>.
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7. Proprietary ingredients
This section is divided into the following subsections:
7.1.
New classification system for proprietary ingredients lodged with the TGA for use in Listed
medicines
7.2.
Data requirements for proprietary ingredients
7.3.
Specific requirements for proprietary ingredients in Listed medicines
7.4.
Labelling associated with proprietary ingredients
The term ‘proprietary ingredient’ (PI) means a confidential formulation usually containing two or
more ingredients and about which information is not in the public domain. PIs include fragrances,
flavours, colouring ingredients, trans-dermal patch adhesives and printing inks. However, where a
pre-mix of active ingredients is used in a PI formulation, the active ingredients must be disclosed. A
single ingredient is not usually acceptable as a PI formulation.
Before a PI is included in a product, the sponsor should ensure that:

formulation and / or processing details have already been disclosed to the Therapeutic Goods
Administration (TGA) (in which case the sponsor should give the ingredient’s Australian
Register of Therapeutic Goods (ARTG) number in the application form) OR

they have asked the manufacturer of the proprietary ingredient to provide the TGA with details
of the formulation on a Notification of a Proprietary Ingredient form, and have obtained the
ARTG PI number to include in the application form.
Sponsors should be aware that there is no evaluation of the PI formulation in terms of safety or
efficacy. However, the individual ingredients of the PI are assessed for safety. For colouring PIs, the
colour must be one that is approved for ingestion if the ingredient is to be used in an oral product.
7.1. New classification system for proprietary
ingredients lodged with the TGA for use in Listed
medicines
New PIs for use in Listed medicines lodged with the TGA are to be categorised into one or other of
five types based on the risk profile of ingredients within them:
Type 1a:
Colours – low risk, often long history of use, generally small quantities in finished
products.
Type 1b:
Fragrances, flavours and printing inks – low risk, often long history of use, generally very
small quantities in finished products.
Type 2:
Active intermediate formulations (active pre-mixes) – relatively high risk as they contain
therapeutically active substances.
Type 3:
Vehicles and coating materials (such as cream, ointment bases and capsule shells) – low
risk, often long history of use.
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Type 4:
Pre-formulated mixes of preservatives – medium risk, as some individuals are sensitive
to some preservatives.
7.2. Data requirements for proprietary ingredients
The following information is required when a new PI for use in Listed medicines is lodged with the
TGA:
1.
The type of PI should be identified;
2.
All ingredients should have approved names consistent with the Australian Approved
Terminology for Medicines (i.e. AAN, ABN, AHN, AHS or PRV); and
3.
Quantitative composition (as a concentration of the total PI) should be provided for all
ingredients.
The only exceptions to 2 and 3 above will be for Type 1b PIs, i.e. fragrances, flavours and printing
inks, where the declaration of quantitative composition and use of Australian Approved
Terminology is not mandatory.
7.3. Specific requirements for proprietary ingredients
in Listed medicines
7.3.1. Type 1a: Colours
Only those PIs that are colours currently approved for pharmaceutical ingestion will be allowed in
Listed medicines. PIs that are colours require:

classification of the PI type;

all ingredients to be in approved names consistent with the Australian Approved Terminology
for Medicines (i.e. AAN, ABN, AHN or PRV); and

quantitative composition (concentration) for all ingredients.
7.3.2. Type 1b: Flavours, fragrances and inks
Type 1b:
Maximum concentration allowed in the final product
Flavours
5%
Fragrances
1%
Inks
0.1%
PIs that are flavours will be allowed in Listed medicines up to a maximum concentration of
5 per cent in the final product. Incorporation beyond this level will require further assessment by
the TGA. Requirements for PIs that are flavours:
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
Classification of the PI type is the only mandatory requirement. The qualitative formulation of
the PI is required, but it is not necessary that this be in Australian Approved Terminology
format, although that is preferred if possible.
PIs that are fragrances will be allowed in Listed medicines up to a maximum concentration of
1 per cent in the final product. Incorporation beyond this level will require further assessment by
the TGA. Requirements for PIs that are fragrances:

Classification of the PI type is the only mandatory requirement. The qualitative formulation of
the PI is required, but it is not necessary that this be in Australian Approved Terminology
format, although that is preferred if possible.
PIs that are Inks will be allowed in Listed medicines up to a maximum concentration of 0.1 per cent
in the final product. Incorporation beyond this level will require further assessment by the TGA.
Requirements for PIs that are inks:

Classification of the PI type is the only mandatory requirement. The qualitative formulation of
the PI is required, but it is not necessary that this be in Australian Approved Terminology
format, although it is preferred if possible.
7.3.3. Type 2: Active intermediate formulations (active pre-mixes)
PIs that are classified as active pre-mixes must contain at least one active ingredient. PIs that are
active pre-mixes require:

classification of the PI type;

all ingredients to be expressed using approved names consistent with the Australian Approved
Terminology for Medicines (i.e. AAN, ABN, AHN or PRV);

quantitative composition (concentration) for all ingredients; and

that the active ingredient be a permitted Listable ingredient as allowed by Schedule 4 of the
Regulations.
7.3.4. Type 3: Vehicles (cream and ointment bases, capsule shells)
PIs that are vehicles require:

classification of the PI type;

all ingredients to be expressed using approved names consistent with the Australian Approved
Terminology for Medicines (i.e. AAN, ABN, AHN or PRV); and

quantitative composition (concentration) for all ingredients.
7.3.5. Type 4: Pre-formulated mixes of preservatives
PIs that are classified as preservatives must contain only Listable ingredients which are permitted
for the proposed route of administration of the finished product. PIs that are preservatives require:

classification of the PI;

all ingredients to be expressed using approved names consistent with the Australian Approved
Terminology for Medicines (ie. AAN, ABN, AHN or PRV); and
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
quantitative composition (concentration) for all ingredients.
Note that for types 1a, 2, 3 and 4 PIs to be eligible for inclusion in Listed medicines, all ingredients
within the PIs must be eligible for inclusion in Listed medicines.
7.4. Labelling associated with proprietary ingredients
Where appropriate, proprietary ingredients may be described as ‘natural’, ‘nature-identical’ or
‘artificial’.
If the label includes a negative disclosure statement (e.g. ‘sugar free’), sponsors should also ensure
that the substance referred to in the negative disclosure statement is not contained in any PI in the
product formulation.
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8. Interface issues
This section is divided into the following subsections:
8.1.
Medicine / Device interface
8.2.
Cosmetic / Medicine interface
8.3.
Medicine / Food interface
8.4.
Complementary / Pharmaceutical medicine interface: route of evaluation
8.1. Medicine / Device interface
A ‘medical device’ is defined in the Therapeutic Goods Act 1989 (the Act) as:

any instrument, apparatus, appliance, material or other article (whether used alone or in
combination, and including the software necessary for its proper application) intended, by the
person under whose name it is – or is to be – supplied, to be used for humans for the purpose of
one or more of the following:
– diagnosis, prevention, monitoring, treatment or alleviation of disease;
– diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or handicap;
– investigation, replacement or modification of the anatomy, or of a physiological process; and
/ or
– control of conception;
and which does not achieve its principal intended action in or on the human body by
pharmacological, immunological or metabolic means, but which may be assisted in its function
by such means; OR

is an accessory to such an instrument, apparatus, appliance, material or other article.
Medical devices include a wide range of products such as medical gloves, bandages, syringes,
condoms, contact lenses, X-ray equipment, heart-rate monitors, surgical lasers, pacemakers,
dialysis equipment, baby incubators and heart valves.
8.1.1. Regulatory system for medical devices
A new regulatory system for medical devices in Australia was introduced in Australia
on 4 October 2002. This new system was established under the Act as amended by the
Therapeutic Goods Amendment (Medical Devices) Bill 2002 and the Therapeutic Goods
(Medical Devices) Regulations 2002.
Following the amendments to the Act, an additional part was created in the ARTG for medical
devices. The new part is for medical devices included in the Register. The parts of the ARTG for
goods known as Registered and Listed goods remain.
Therapeutic goods, which are currently Registered or Listed in the ARTG, cannot be transferred to
the new part. An application will be required to have a medical device included in the ARTG.
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Sponsors are encouraged to use the Devices Electronic Application Lodgement system (DEAL) for
these applications.
The guidance document, the Australian Regulatory Guidelines for Medical Devices(ARGMD), has been
developed to help explain the new regulatory system for medical devices.
8.1.1.1. Transition period
The Act as amended by the Therapeutic Goods Amendment (Medical Devices) Act 2002, has made
provision for the following transition periods for certain therapeutic goods, as follows:

Medical devices that are currently Registered or Listed goods in the Australian Register of
Therapeutic Goods (ARTG) can remain Registered or Listed until 4 October 2007. However, any
Registered or Listed therapeutic devices in the ARTG after that date will be automatically
cancelled. During the transition period, an application can be made to include those goods in
the ARTG. If the application for inclusion is successful the Registration or Listing will then be
cancelled; OR

Medical devices that are exempt goods will remain exempt until 4 October 2004. After that
time, those goods, if they no longer satisfy the definition of exempt goods, will have to become
medical devices included in the ARTG so that they can be supplied in Australia; OR

Applications for entry in the ARTG for Listable therapeutic devices manufactured in Australia
that do not currently require a manufacturing licence from the TGA will still be accepted until 4
October 2004.
8.2. Cosmetic / Medicine interface
This subsection is intended to provide guidance in relation to the cosmetic / therapeutic interface
in respect of product claims; however, it is not an exclusive or exhaustive listing. The industry
association representing the manufacturers and distributors of cosmetics – the Cosmetic, Toiletry
and Fragrance Association of Australia (CTFAA) – has a Code of Conduct which also provides
guidance on the cosmetic / therapeutic interface is ACCORD Australasia Limited
(<http://www.accord.asn.au>).
Products are determined to be either ‘cosmetics’ or ‘therapeutic goods’ on the basis of two factors:

the composition of the product; and

the proposed use of the product.
8.2.1. Composition
The composition of a product does not necessarily determine its classification. However, it is quite
possible that an ingredient, or the concentration of an ingredient, may make the product unsuitable
for classification as a cosmetic.
8.2.2. Proposed use
According to the definitions of the terms ‘therapeutic goods’ and ‘cosmetic products’ in the
legislation, the key consideration for the classification of a product is its proposed use. The claims
made in package inserts, in advertisements, and especially in product labels, indicate to the
consumer the intended use of the product. It is also important to consider the context in which the
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product is marketed. Claims that indicate the product is a therapeutic good (medicine) cannot be
made for a product marketed as a cosmetic.
8.2.3. Legislation
The TGA administers the Act and the Therapeutic Goods Regulations 1990 (the Regulations).
Products subject to this legislation are ‘therapeutic goods’, i.e. products intended for ‘therapeutic
use’ which includes ‘modifying a physiological process’. Normally, cosmetic products do not come
within the ambit of this legislation. However, if a product claims to modify a physiological process
(or treat or prevent disease) then it falls within the ambit of the legislation and requires inclusion in
the ARTG before supply of the goods.
Specific legislation concerning cosmetic products is the Trade Practices (Consumer Product
Information Standards) (Cosmetics) Regulations administered by the Treasury. The scope of the
legislation is limited to requirements concerning ingredient labelling information. ‘Cosmetic
product’, as defined in the information standard, means a substance or preparation intended for
placement in contact with any external part of the human body, including the mucous membrane of
the oral cavity, and the teeth, with a view to achieving one or more of the following:

altering the odours of the body;

changing its appearance;

cleansing it;

maintaining it in good condition;

perfuming it; and / or

protecting it.
8.3. Medicine / Food interface
This subsection is intended to provide general guidance on the interface between foods and
therapeutic goods.
The sale and supply of ‘therapeutic goods’ is regulated by the Act and its associated Regulations and
Therapeutic Goods Orders. Some provisions, such as the scheduling of substances and the safe
storage of therapeutic goods, are covered by State or Territory legislation.
The sale and supply of ‘food’ is regulated by State and Territory food legislation with the import of
food regulated by Commonwealth legislation. These sets of legislation uniformly adopts the
Australia New Zealand Food Standards Code (the Code), but apply additional requirements and
restraints over and above those stipulated in the Code.
8.3.1. Food Standards Australia New Zealand (FSANZ)
Food Standards Australia New Zealand (FSANZ) is a statutory authority operating under the Food
Standards Australia New Zealand Act 1991 (the FSANZ Act).
FSANZ works in partnership with the Australian, State and Territory governments and the New
Zealand Government, to protect the health and safety of the people in Australia and New Zealand by
maintaining a safe food supply.
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The TGA works closely with the FSANZ, particularly with respect to products at the food / medicine
interface.
8.3.2. Differentiation between therapeutic goods and foods
The differentiation between food and medicines is defined through the Act FSANZ Act. Where
necessary, both Acts enable the regulators to declare a product as either a ‘therapeutic good’ or a
‘food’, to maintain clarity at the food / medicine interface.
Key considerations in determining when a substance or product is considered a food or therapeutic
good include:

the composition or nature of the substance or product;

the presentation of the substance or product, including any representations in labels or
advertising; and

the intended use or purpose for the substance3 or product, including any tradition of use.
8.3.2.1. Therapeutic goods
Therapeutic goods are those products that are represented in any way to be, or likely to be taken to
be, for therapeutic use or for use as an ingredient in the manufacture of a therapeutic good.
‘Therapeutic use’ is defined in the therapeutic goods legislation. However, a therapeutic good does
not include:

goods declared not to be therapeutic goods4;

goods for which there is a prescribed standard in the Code (need to include recent
amendments in therapeutic goods legislation that reduces the impact of this exclusion); and /
or

goods which, in Australia or New Zealand, have a tradition of use as foods in the form in which
they are presented.
8.3.2.2. Foods
Foods include:

any substance used for human consumption, including live animals and plants;

any substance used as an ingredient or additive in a food referred to in (a);

any substance used in preparing a substance referred to in (a);

chewing gum or an ingredient or additive in chewing gum; and

any substance or thing declared to be a food.
In considering whether a substance or product is a food or a therapeutic good, it should be noted
that food labels and advertising must not:

include a claim for therapeutic or prophylactic action;

include the word ‘health’ as a part of the name of the food;

contain any advice of a medical nature from any person; and
3
The use of a substance in a therapeutic good does not preclude its use as a food, e.g. garlic (subject to the provisions
of the Code).
4 There is power in the Act to declare goods to be, or not to be, therapeutic goods (Section 7).
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
include the name of, or a reference to, any disease or physiological condition.
A review of health claims on food is currently being undertaken. In order to preserve the integrity
of Australia’s food / medicine interface, the review will attempt to ensure a ‘level playing field’ for
the regulation of claims on either side of the interface.
8.3.3. Food / Medicines interface group
From time to time, sponsors and regulators of medicine or food products need access to a
mechanism that can provide clarification as to the regulatory status of products which fall at or
near what is known as the ‘food / medicines interface’. For this reason, the Foods / Medicines
Interface Group was established to provide advice to sponsors, food manufacturers, TGA
surveillance staff and food enforcement officers on the compliance of certain products with food or
medicines legislation.
The Interface Group comprises members from FSANZ, the TGA and the Australian Quarantine
Inspection Service (AQIS). The group meets on an as-needed basis to discuss, case-by-case, specific
products forwarded to it and to make suggestions as to whether a product is more appropriately
regulated as a food or a medicine. The advice provided by the group often consists of suggestions
about labelling or compositional changes that may be needed to make the regulatory status of the
particular product clearer.
In providing its advice for a particular product, the group takes into consideration a number of
factors including:

the presentation of the product;

whether or not the product is likely to be consumed as a therapeutic good or as a food;

the composition and ingredients;

the physical form, i.e. liquid, capsule, powder, bar or other food form;

the suggested directions for use and / or prescribed dosage regime;

the labelling;

any claims made;

the way the product is marketed and / or promoted; and

if it is covered by a food standard in the Code.
The advice provided by the Interface Group is always subject to the legislative framework in which
products are considered. Changes to the legislation for both foods and therapeutic goods over time,
such as the changes to therapeutic legislation in relation to Section 7 5 declarations, are taken into
account by the Interface Group when considering particular products.
The advice of the Interface Group should not be considered as ‘decisions’, because the group has no
statutory power to make decisions. The advice given is the group’s best understanding of the
regulatory frameworks for foods and medicines and its interpretation of those frameworks as they
apply to particular products.
Sponsors of complementary medicines seeking advice of this nature may contact the Office of
Complementary Medicines (OCM) in the Therapeutic Goods Administration (TGA) or, if the product
is more likely to be a food, then sponsors should contact FSANZ, by telephone, on its advice line
1300 652 166.
5
More information on Section 7 of the Act can be found in the ARGCM Part V – Policy.
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8.4. Complementary / Pharmaceutical medicine
interface: route of evaluation
Medicines are evaluated by one or other or all of three regulatory units. Complementary medicines
are evaluated by the OCM, prescription and over-the-counter (OTC) medicines by the Office of
Medicines Authorisation (OMA). The criteria for deciding which of these units evaluates a particular
medicine are set out in Schedule 10 to the Regulations.
In some circumstances, it may be more appropriate for a particular medicine to be evaluated by a
different unit to the one specified in Schedule 10. The Regulations allow for the transfer of
applications between the regulatory units. Once transferred, the applications are dealt with
according to the requirements (e.g. fees and data requirements) of the new area. A decision to
transfer an application to a different regulatory unit may be taken at the initiative of the TGA
delegate. In such cases, the sponsor will be advised before the transfer takes place and be given the
opportunity to comment.
Where a sponsor wishes to have an application dealt with by an evaluation unit other than the one
specified in Schedule 10 to the Regulations, they will need to provide a justification to the TGA to
establish that this is appropriate. The justification can be provided separately in advance of an
application or as part of the application itself. If the justification is accepted, the application for that
product or substance will then be dealt with by the new evaluation unit in the same way as other
products / substances regulated by that unit (e.g. application and evaluation fees and data
requirements will be those of the new evaluation unit).
If the justification is refused, any subsequent application for that product will be dealt with
according to Schedule 10 to the Regulations. Details of a procedure for appeals are included later,
under ‘Administrative Details’. The information required in a justification will vary depending on
the current and proposed route of evaluation.
8.4.1. OCM to OTC or vice versa
In general, products containing active ingredients that would normally be evaluated as OTC
medicines (e.g. paracetamol) in combination with active ingredients that would normally be
evaluated as complementary (e.g. herbal substances, vitamins, minerals) will be evaluated via the
OTC route. Where a sponsor wishes to propose a different route, a justification must be provided.
8.4.2. Prescription to OTC or OCM
Products containing new active substances (i.e. those that are not included in any medicine
currently authorised for sale in Australia) are evaluated by the OMA. Exceptions to this general rule
are complementary medicines substances (evaluated by OCM). Where a justification for evaluation
of a product or substance via the OCM route is proposed, the primary factors to be taken into
account include:

the safety of the active substance;

the need for professional counselling before use;

the nature of the ailments or symptoms to be treated (can they be easily recognised by the
consumer, do they require medical diagnosis or management?);

the abuse potential of the product or substance;

the incidence of adverse effects and contraindications;
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
the risk of masking serious disease; and

the risk / benefit profile of the product (e.g. therapeutic index).
Other factors that may be taken into account include whether or not:

the product would be in a lower schedule (or unscheduled) in the Standards for the Uniform
Scheduling of Medicines and Poisons (SUSMP), if presented in a different form (e.g. different
pack size, different strength, different indications, different route of administration);

products containing the substance are available without prescription in other countries with
comparable regulatory regimes to Australia;

the product contains a substance that has a closely related chemical structure and similar
therapeutic action to other substances that are in a less-restrictive schedule (or are
unscheduled); and

the substance appears to meet the criteria for Listing.
8.4.3. OCM to Prescription
In some circumstances, sponsors may prefer to have an application evaluated by the OMA rather
than the OCM (e.g. where a product range includes strengths that are prescription as well as
Listable). A justification should be submitted, but minimal supporting data will be required in such
cases.
8.4.4. Excipients
Excipients are usually evaluated via the same route as the products in which they are to be used
(e.g. a new excipient that is to be used in a complementary medicine will be evaluated by the OCM).
In general, the evaluation criteria for new excipients are common across all areas of the TGA.
Information on data requirements is available from the evaluation area applicable.
8.4.5. Currently registered non-prescription transdermal patches
Under Schedule 10 to the Regulations, transdermal systems are routinely evaluated by the OMA,
even if they are non-prescription products. Notwithstanding this, evaluation of a particular
application via the OCM route will be accepted when it involves a change or changes that do not
result in a new delivery system or influence the characteristics of the currently approved delivery
system. Changes in formulation, membrane or other specific factor(s) that control release of the
active ingredient frequently result in what could be considered a new delivery system.
Acceptable changes (i.e. to be considered by the OCM route), therefore include applications
involving clinical data, toxicological data, and only those pharmaceutical chemistry changes that do
not create a new transdermal system or influence the characteristics of the currently approved
system. Examples of changes that will be accepted for evaluation via the OCM route are:

labelling changes;

sponsor changes;

Consumer Medicine Information (CMI);

Product Information (PI);
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V4.2 August 2011
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
packaging changes, other than immediate packaging; and

product detail changes not involving a change to the delivery system.
Changes other than those specified will require a justification if an alternative evaluation area is
desired. Such changes would include, for example:

product detail changes involving the delivery system;

quality control changes – finished-product specifications which do not result in a new
transdermal system;

quality control changes – starting material specifications which do not result in a new
transdermal system; and

manufacturing changes – finished product.
8.4.6. Administrative details
A form (‘Justification for a particular route of evaluation’) is provided to assist sponsors in
submitting the required information. The justification request should be submitted to the
evaluation unit specified in Schedule 10 to the Regulations (e.g. a ‘prescription only medicine’
(Schedule 4 to the SUSMP) justification request should be submitted to the OMA) with a copy sent
to the proposed evaluation unit. There is no fee for this.
A decision will be made by the TGA within 20 working days (four weeks) of receipt of the
justification request. The decision will be made by the relinquishing area following discussion with
the proposed receiving area.
The sponsor will be advised of the decision by the relinquishing area. If the initial decision is to
refuse the justification request, the reasons for refusal will be given.
Following the initial decision, if the sponsor and the TGA cannot come to a mutually acceptable
position, the sponsor may ask the TGA National Manager to undertake an independent internal
review. This review will be completed within 20 working days of the receipt of the request and may
involve consultation with the chairs of the relevant evaluation committees.
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9. Australian native and
endangered species in
therapeutic goods
This section is divided into the following subsections:
9.1.
Background
9.2.
The role of the Therapeutic Goods Administration
9.3.
More information
This section provides guidance to sponsors on their responsibilities regarding the use of
ingredients that may be regulated under the Environment Protection and Biodiversity Conservation
Act 1999 as either native species and / or identified under the Convention on International Trade in
Endangered Species of Wild Fauna and Flora (CITES).
9.1. Background
Australia’s unique plants and animals are known throughout the world and are a part of our natural
heritage. The Australian Government recognises the value of our native species and the need to
ensure their continued survival. Regulation of international movement (exports and imports) of
wildlife and wildlife products is acknowledged internationally as an important element of effective
nature conservation. In addition to protecting native species, the Australian Government reinforces
the efforts of other countries to protect their wildlife by regulating trade in those species identified
under CITES (<http://www.cites.org>). These controls, as well as contributing to the international
cooperative conservation effort, also complement the wildlife conservation efforts of Australian
States and Territories.
For all wildlife except cetaceans (whales, dolphins etc.), international movement of wildlife and
wildlife products is regulated under Part 13A of the Environment Protection and Biodiversity
Conservation Act 1999. Sections 232A and 232B of Part 13 of this Act cover cetaceans. The
Environment Protection and Biodiversity Conservation Act 1999 regulates the:

export of Australian native species other than those identified as exempt;

export and import of all species that are recognised internationally as endangered or likely to
become so if trade is not strictly regulated;

importation of species identified by other CITES member countries as requiring international
cooperation to regulate their trade; and

importation of live plants and animals that, if they became established in Australia, could
adversely affect native species or their habitats.
Commercial export of regulated wildlife and wildlife products may occur only where the specimens
have been derived from an approved source (a captive breeding program, an artificial propagation
program, an aquaculture program, a wildlife trade management operation, or a wildlife
management plan).
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V4.2 August 2011
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The importation of CITES listed specimens for commercial purposes must be from an approved
commercial import program or approved captive source, and is subject to specific conditions
(303CH) described in the particular appendix on which the specimen is listed. Specific conditions
(303CH) also apply to the commercial export of CITES-listed species.
9.2. The role of the Therapeutic Goods Administration
The Therapeutic Goods Administration (TGA) does not have the legislative power to reject Listing
or Registration applications on the grounds that they contain a substance derived from a species
that is subject to State or Australian Government environmental regulation. This may result in the
situation where therapeutic goods that are Listed or Registered on the Australian Register of
Therapeutic Goods (ARTG) may be seized at Customs if they are exported or imported. Therefore, it
is the responsibility of sponsors of therapeutic goods containing substances that are derived from
Australian native or endangered species to:

be aware that controls on the trade of these goods may exist

take appropriate steps to avoid action by enforcers of the Commonwealth Department of
Sustainability, Environment, Water, Population and Communities or by Customs officers.
While the TGA does not play a role in the administration or enforcement of Environment Protection
and Biodiversity Conservation legislation, the TGA is obligated to take reasonable steps to prevent
the illegal trade of endangered and Australian native species. In order to meet these obligations, the
TGA will release to the Commonwealth Department of Sustainability, Environment, Water,
Population and Communities information about therapeutic goods that contain substances derived
from endangered or Australian native species.
While the TGA will continue to treat commercial-in-confidence information in accordance with
legislated requirements, Section 61(6) of the Therapeutic Goods Act 1989 allows the release of
therapeutic goods information. Regulation 46 of the Therapeutic Goods Regulations 1990 (the
Regulations) describes the kinds of therapeutic goods information that the Secretary may release.
As described in Regulations this information may include:

the name of the therapeutic goods;

the name and address of the sponsor of the goods;

the names and quantities of therapeutically active substances in the goods; and

the presence or absence of any specific excipient in the goods.
9.3. More information
For further information on how to comply with Regulations controlling the trade of Australian
native or endangered species, and products derived from them, within Australia, sponsors should
contact the Environmental Protection Authority in their State.
For further information on how to comply with Regulations controlling the import / export of
Australian native or endangered species, and products derived from them, sponsors should contact
the Commonwealth Department of Sustainability, Environment, Water, Population and
Communities (telephone: 02 6274 1111; fax: 02 6274 1666, website:
(<http://www.environment.gov.au>).
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V4.2 August 2011
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10. Other legislation
Sponsors developing therapeutic goods for supply in Australia should be aware of the requirements
applicable under other Commonwealth, State and Territory legislation such as those concerning:

trade practices;

weights and measures;

deceptive packaging;

Customs (Prohibited Imports) Regulations;

Quarantine;

State / Territory therapeutic goods legislation;

State / Territory drugs and poisons scheduling;

Advertising; and

genetically modified organisms or genetically modified products.
Listing of a product in the Australian Register of Therapeutic Goods (ARTG) does not
absolve it or its sponsor from the provisions of other relevant legislation.
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11. Certificates of analysis
– product
A certificate of analysis (used for ‘release for supply’ purposes) is a document certified as a truthful
statement of the tests and test results for an individual, manufactured batch of a particular product.
The certificate should identify at least:

the primary manufacturer;

the product;

the date of the certificate and the date of the testing;

the batch of the product;

the tests and the test results;

the acceptable test specifications; these are the test limit or the range of results for each test
with which the batch must comply before release for supply; and

the signature of the appropriate company official.
The range of tests applied to a product is at the discretion of the manufacturer and will depend on a
number of factors including the type(s) of active ingredients and the pharmaceutical dosage form.
Reference should be made to standard pharmacopoeial texts for guidance on tests and test
methods. Some products are also subject to requirements under Therapeutic Goods Orders.
For example, a herbal tablet formulation should include tests for at least:

identity tests for the presence of actives;

disintegration time;

uniformity of weight;

assay of actives (if possible); and

tests for contaminants (if the starting materials are not tested for these individually) such as
microbiological contaminants, heavy metals and foreign matter.
Sponsors should also make reference to the guidance document Quantified By Input. This guidance
describes the criteria under which a manufacturer is not required to analyse an ingredient in a
finished product. It also details the wording that should be used on a certificate of analysis, where
an actual ingredient has been ‘quantified by input’.
On occasions, a certificate of analysis may not be available for a manufactured batch at the time of
lodging an application for Listing. In such cases, a statement of the intended tests and test
specifications for an acceptable batch should be available.
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V4.2 August 2011
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12. Product Specifications
The product specification is a description of the product formulation, and the tests to be applied to
batches of the product.
The statement should contain (or make reference to):

name of product;

dosage form;

product code;

date of specification;

revision or version number;

name and signature of the appropriate company official;

description of physical appearance;

detail of physical tests performed (and limits) including total weight, weight variation, tests
and limits, disintegration tests and limits;

stage of manufacture;

packaging type and closure;

recommended storage conditions;

recommended shelf-life; and

details of the full formulation including all active and all excipient ingredients (including
coatings and capsule shell ingredients).
For every ingredient:

give the Australian Approved Name (AAN);

state the quality standard and / or grade;

state any overages used;

state the nominal (label claim) amount:
– Clearly identify whether the amount of substance is expressed in terms of the salt / complex,
or base. If the label claim is not in the same terms, the amount in terms of the label statement
should also be stated; and
– If the ingredient is herbal, the TGA Approved Terminology for Medicines (Chapter 1, Section 3
– Herbal Substances) offers useful guidance. Include, for example, the botanical species, plant
part and, if an extract, state the amount of the extract, the strength of the extract, and the
equivalent amount of dried plant. The extracting solvent and diluting medium should also be
described.
– Guidance on the identification of herbal materials and extracts is provided in the document
titled Questions & Answers for the Identification of Herbal Materials and Extracts, available at
<http://www.tga.gov.au/industry/cm-identification-herbal-extracts.htm> on the TGA
website; and
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V4.2 August 2011
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– If direct compression (DC) tableting materials are used, then, as with herbal extracts,
describe the amount of DC material used, its equivalence to active substance, and describe
the diluent.
For each active ingredient state:

what is analysed in each batch;
what is analysed on rotation, and the frequency (see the guidance document Quantified by Input);

what is not analysed at all, and how the ingredient’s presence is verified in such cases;

describe briefly the analytical procedure (HPLC, AA, TLC) applied to each ingredient in the final
product;

unless covered in a separate document, the release limits – upper and lower; and

unless covered in a separate document, the expiry limits – upper and lower.
If declarations are to be made about the absence of any substances in the product, then Proprietary
Ingredients, such as colourings and flavours and ingredient diluents, should be checked to ensure
the accuracy of such declarations.
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13. Enforcement
procedures
This section is divided into the following subsections:
13.1.
Listed medicines
13.2.
Post market monitoring
13.3.
Listing Compliance Section (LCS) of the OCM
13.4.
Regulatory action
13.1.Listed medicines
Under the Listing process, medicines will be Listed in the Australian Register of Therapeutic Goods
(ARTG) on the basis of their sponsor’s provision of information and a declaration that the product
is eligible for Listing and complies with all Listing requirements.
The Therapeutic Goods Act 1989 (the Act) provides for the immediate cancellation of a product’s
Listing if the application is found to have been falsely certified and the product to be ineligible for
Listing. Recall of any distributed goods will be required in such cases and whenever public safety is
at risk as a result of product non-compliance. Major or repeated offences against the Act and the
Therapeutic Goods Regulations 1990 (the Regulations) may lead to prosecution by the Therapeutic
Goods Administration (TGA).
13.2.Post market monitoring
The regulation of complementary medicines in Australia through the TGA’s Listed medicine system
allows for early market access for low-risk complementary medicines. In facilitating early market
access, there is reliance on a comprehensive risk-based system for the post market monitoring.
The objectives of the TGA’s post-market program covering complementary medicines are to:

provide assurance of the safety of complementary medicines through a risk-based program of
post market monitoring and surveillance;

provide consumer confidence in the safety and quality of complementary medicines; and

ensure industry compliance with regulatory standards and guidelines for complementary
medicines.
The measures required to meet the objectives include:

targeted and random desk-based audits of Listed medicines;

monitoring of suspected adverse reactions;

targeted and random laboratory testing of medicines and ingredients;

targeted and random surveillance in the market place;
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
an effective, responsive and timely recalls procedure;

audit of good manufacturing practice (GMP); and

an effective co-regulatory approach to control advertising.
These measures provide timely identification and appropriate regulatory responses to problems
associated with the formulation, manufacture, labelling and advertising of medicines.
13.3.Listing Compliance Section (LCS) of the OCM
The Office of Complementary Medicines’ (OCM) Listing Compliance Section (LCS) has five areas of
activity:

monitoring of complementary medicines Listed on the ARTG through the Electronic Listing
Facility Version 3 (ELF 3);

investigation of medicines for which a potential problem has been identified;

reviewing evidence supporting indications and claims made for Listed complementary
medicines;

regulatory action; and

administration and business processes.
The LCS carries out the regulatory actions associated with ELF 3 monitoring, medicine investigation
and evidence reviews. Typically, these actions include:

Section 28 notices (additional conditions);

Section 29D notices (suspension)

Section 30 notices (cancellations and proposals to cancel);

Section 30EA (recalls); and

Section 31 notices (request for information).
13.4.Regulatory action
Where a post-Listing review reveals minor technical errors that do not have significant safety
implications, applicants will be advised that the product is subject to cancellation, but that the TGA
will consider a submission setting out proposed corrective action.
Depending on the individual circumstances, this action may include recovery of distributed stock,
relabelling before further distribution, over-labelling to an appropriate level or correction within a
stated period, and lodgement of appropriate variation applications.
Where a submission is not received, the matter will be dealt with through the standard cancellation
and prosecution powers under the Act.
Any cancellation by the TGA is subject to appeal to the Minister of Health and Ageing and
subsequently to the Administrative Appeals Tribunal (AAT).
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Part IV, Section 13 – Enforcement procedures
V4.2 August 2011
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14. Review of decisions
This section is divided into the following subsections:
14.1.
Appeal mechanisms (Section 60 appeals)
14.2.
The Administrative Appeals Tribunal (AAT)
14.3.
Federal Court
All decisions made by the Therapeutic Goods Administration (TGA) are subject to appeal. This
includes decisions to request information (Section 31 of the Therapeutic Goods Act 1989), to impose
conditions of Registration or Listing (Section 28) or to cancel products from the Australian Register
of Therapeutic Goods (ARTG) (Section 30).
If there is disagreement with a decision made by the delegate of the Secretary, a review may be
sought. Several procedures are available (see Section 60 of the Act).
14.1.Appeal mechanisms (Section 60 appeals)
Decisions by the Secretary of the Department of Health and Ageing, or a delegate of the Secretary,
that are subject to review following a request for reconsideration may be appealed under Section
60 of the Act. Examples include:

a refusal to Register or List goods on the ARTG;

the variation or addition of conditions applying to a Registration or Listing;

cancellation of a Registration or a Listing; and

revocation or suspension of a manufacturing licence.
If a decision can be appealed, details of the appeal rights will usually accompany the decision.
Appeals must be lodged within 90 days of decisions.
The appeal letter should be sent to:
The Parliamentary Secretary to the Minister for Health and Ageing
Parliament House
CANBERRA ACT 2600
and should be clearly marked Appeal under Section 60 of the Therapeutic Goods Act 1989.
It would assist early consideration of the request for reconsideration if a copy of the letter were
sent to the TGA National Manager.
The Minister, or the Minister’s delegate for this purpose, may confirm or revoke the initial decision
or substitute a new decision. If a sponsor has not received a response from the Minister or the
Minister’s delegate within 60 calendar days of receipt of the appeal, the first decision is deemed to
be upheld.
If a sponsor wishes to appeal, but is unable to do so before the 90-day deadline, then the sponsor
should contact the TGA to request an extension of time. This is given only in exceptional
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circumstances. Written details of the reason for the inability to lodge the appeal in the specified
time should be provided.
14.2.The Administrative Appeals Tribunal (AAT)
If not satisfied with the outcome of a Section 60 appeal, an application may be made to the
Administrative Appeals Tribunal (AAT) for review. Applications to the AAT must be made within 28
calendar days of the Minister’s decision regarding a Section 60 appeal.
The AAT may affirm the decision, vary it or set it aside, substitute a new decision, or refer the
decision back to the original decision maker.
14.3.Federal Court
Whereas the AAT provides a merit review process, affected parties may appeal at any time to the
Federal Court, on the grounds of the legality of a decision.
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Part IV, Section 14 – Review of decisions
V4.2 August 2011
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15. Genetically Modified
Organisms
This section is divided into the following subsections:
15.1.
Definitions
15.2.
TGA assessment of GMOs and GM products
15.3.
Gene technology legislation
15.4.
Labelling
15.5.
More information
15.1.Definitions
Section 10 of the Gene Technology Act 2000 (the GT Act) defines a genetically modified organism
(GMO) as:

an organism that has been modified by gene technology; OR

an organism that has inherited particular traits from an organism (the initial organism), being
traits that occurred in the initial organism because of gene technology.
Further, a genetically modified product (GM product) is defined in Section 10 of the GT Act as a
thing (other than a GMO) derived or produced from a GMO.
GMOs have parts of their genetic material (DNA) altered in a way that does not occur naturally by
mating and / or natural recombination; i.e. they are deliberately modified using modern methods of
biotechnology (such as recombinant DNA, molecular and / or cell-biology) to exhibit one or more
traits that do not exist in / are new to the species.
Plants grown using techniques such as hybridisation and selective cultivation are not considered to
be GMOs.
The decision as to what is a GMO or GM product made available for supply under the Therapeutic
Goods Act 1989 is decided in the first instance by the Therapeutic Goods Administration (TGA),
based on the definition of a GM product under the gene technology legislation.
15.2.TGA assessment of GMOs and GM Products
The Therapeutic Goods Administration (TGA) will assess the safety, quality and, where relevant,
efficacy of an application relating to a GMO or GM product by the same means as any other
application relating to a therapeutic good. Sponsors of therapeutic goods containing GMOs or GM
products should therefore provide the same information with the same detail to allow evaluation of
safety, quality (and efficacy) as stipulated in the other parts of the Guidelines.
Australian Regulatory Guidelines for Complementary Medicines,
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V4.2 August 2011
Page 46 of 106
15.3.Gene technology legislation
The GT Act, which came into force on 21 June 2001, introduced a national scheme for the regulation
of GMOs in Australia, in order to protect the health and safety of Australians and the Australian
environment. The GT Act establishes a statutory officer, the Gene Technology Regulator (the GT
Regulator), to administer the legislation and make decisions under the legislation.
The legislation requires all dealings with GMOs (that are not exempt or notifiable low-risk dealings
(see below)) to be licensed by the GT Regulator. Dealings with GMOs may be entered on the GMO
Register once they have been licensed for a certain period of time.
The Gene Technology Regulations also set out categories of dealings with GMOs that are very low
risk and which may proceed provided that certain conditions spelt out in the regulations are
observed (notifiable low-risk dealings).
This will include requirements that the specified dealings be undertaken only in contained facilities,
overseen by Institutional Biosafety Committees (IBCs) and notified to the GT Regulator. These will
be similar to class licences, and the conditions under which such dealings will operate will be
clearly set out in the Regulations.
Where the GT Regulator is confident that a certain dealing involves a very low risk, the class of
dealing with the GMO will be recorded in the Regulations as exempt (e.g. contained research
involving a very well understood process for creating and studying a GMO).
This will mean that no licence is required, provided that the activity remains within the specified
parameters. There will be no exemptions for any release of a GMO into the environment (e.g. field
trials and commercial releases).
The GT Act does not allow dealings that involve the intentional release of a GMO into the
environment to be prescribed as a notifiable low-risk dealing.
The regulatory scheme requires the GT Regulator to take action in respect of GM products assessed
by the TGA in two instances:

to maintain a public record of GMOs and GM products; and

to promote an exchange of advice on issues relating to GMOs or GM products.
15.3.1. Public record
Section 138 of the GT Act requires the GT Regulator to maintain a public record of GMOs and GM
products that are available for supply in Australia. This requirement applies to therapeutic goods.
Information supplied to the TGA in relation to GM ingredients in therapeutic goods will be made
available to the GT Regulator and placed on the public record unless sponsors apply to have data
regarded as confidential commercial information (see below).
The Gene Technology Regulations prescribe the particular information to go on the Record in
relation to GMOs or GM products. The following information is required:

the name of the organisation producing the GMO or GM product (i.e. the manufacturer of the
product, rather than the supplier)

a description of the GMO or GM product with reference to:
– the Therapeutic Goods Act 1989 (the Act), e.g. Listed medicine, vaccine; and
– its common name as a product, or type or class of product, e.g. insulin

information about the GMO or GM product, including:
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Part IV, Section 15 – Genetically Modified Organisms
V4.2 August 2011
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–
–
–
–
the common name and the scientific name of the parent organism involved;
details of the introduced trait in the GM product;
the identity of the introduced gene responsible for conferring the introduced trait; and
whether the product contains viable GMOs.

the date on which a decision under therapeutic goods legislation that enables supply of the
GMO or GM product in Australia takes effect; and

details of any conditions attached to that permission.
Where a GM product is approved by the TGA, the information set out above, including that provided
by the sponsor, will be made publicly available on the Record of GMOs and GM Product dealings. An
application for the information to be treated as commercial-in-confidence may be submitted to the
GT Regulator under Section 184 of the GT Act. The GT Regulator will provide the sponsor with a
reasonable time in which to make such an application. However, the responsibility for such an
application lies with the sponsor not the TGA or the GT Regulator.
15.3.2. Exchange of advice on GMOs or GM products
The GT Regulator does not directly regulate the use of GM products in Australia. However, the gene
technology legislation prescribes a licensing system for dealings with live, viable GMOs. After the
TGA has assessed an application relating to a GMO or GM product, Section 30C of the Act requires
the TGA to inform the GT Regulator that:

an application has been made relating to a GMO or GM product; and

advice is sought from the GT Regulator about the application.
Where the TGA is required to seek the advice of the GT Regulator in relation to a GM product
application, the TGA will write directly to the Regulator asking for such advice. The GT Regulator
may accept the advice of the TGA in relation to the health and safety aspects of an application
relating to a GMO or GM product. However, the GT Regulator may also provide advice to the TGA on
other aspects of the application, including matters relating to the environmental release of GMOs or
GM products. The TGA must take this advice into account in assessing the application relating to a
GMO or GM product.
15.4.Labelling
Therapeutic goods legislation does not require a declaration on the product label that the
therapeutic good is or is not derived from a GMO. However, applicants should establish and
maintain documentation about GMOs or substances derived from GMOs, so that they are in a
position to:

provide definitive information to consumers should it be requested;

comply with any other legislation that requires this information to be declared; and

be prepared in case future legislative changes to therapeutic goods legislation make the
declaration of this information mandatory.
Sponsors should make reference to the other legislation that applies to therapeutic goods in
relation to GMOs.
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V4.2 August 2011
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15.5.More information
Sponsors intending to apply to the TGA to use a GMO as a medicinal product (including use in a
clinical trial) are advised to also consult the Office of the Gene Technology Regulator (OGTR) to
determine their obligations under the GT Act. Further information can be obtained from the OGTR
website at <http://www.ogtr.gov.au>
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V4.2 August 2011
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16. Medicines for export
This section is divided into the following subsections:
16.1.
Medicines already approved for supply in Australia
16.2.
‘Solely for Export’ medicines
The export of medicines from Australia, including prescription, over-the-counter (OTC) and
complementary medicines, is regulated by the Therapeutic Goods Administration (TGA) in order to
protect health and safety by ensuring that exported medicines are of a similar quality and safety
standard to those supplied domestically.
The TGA:

requires that medicines exported from Australia comply with necessary quality and safety
standards;

approves the supply of medicinal products for export;

issues export certificates (including certificates issued under the World Health Organization
(WHO) Certification Scheme); and

communicates with other regulatory authorities to maintain awareness of any potential quality
and safety issues.
16.1.Medicines already approved for supply in Australia
Medicines, including complementary medicines, approved for supply in Australia are automatically
approved also for export by the sponsor or their agent, subject to other applicable export
legislation.
If a product has to include specific warning statements on its label in order to be eligible for Listing
in the Australian Register of Therapeutic Goods (ARTG) for domestic supply, and it is also to be
exported, these warning statements must remain on the label in order for the Australian Listing
approval to extend to the exported product. Warning statements may be omitted only where the
product is separately listed solely for export.
16.2.‘Solely for Export’ medicines
Medicines intended solely for export, including products that would be regarded as complementary
medicines in Australia, must be Listed (not Registered) on the ARTG before export. Broadly, they
must:

be safe for their intended purpose of use;

be manufactured under conditions of good manufacturing practice (GMP);

meet any standards applicable under Section 10 of the Therapeutic Goods Act 1989 (the Act);
and

not be of an unacceptable presentation.
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V4.2 August 2011
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Efficacy requirements are similar to those applying to other Listed products on the ARTG, and
sponsors must hold evidence in support of claims made on ‘solely for export’ products.
Advisory statements on ‘solely for export’ products are often associated with the types of
indications permitted for the product within the regulatory framework of the country of
destination. It is the sponsor’s responsibility to ensure that any advisory statements needed are
included on the product label as required by the importing countries.
The export regulatory framework aims to provide necessary protection to the international
community in terms of the safety and quality of products, while acknowledging that there are often
valid reasons why products manufactured and listed exclusively for export are not able to be
supplied on the Australian market. the export only products are required to go through a quality
and safety assessment prior to listing them on the ARTG.
As part of the TGA’s commitment to supporting a strengthened understanding in the importing
country of the regulatory status of the product in Australia, the TGA may include a clarification
statement on the export certificate for ‘export only’ medicines. In addition to simply certifying that
the product is not listed for supply in the exporting country domestic use (as is required under the
WHO Certification Scheme). I may include clarification statements for example:

“This product has the same formulation as another product on the Australian market which is
supplied in a different container or packaging (include AUST L / R number).”

“The product approved for supply in Australia has been reformulated to exclude excipients not
approved in the importing country.”

“This product has been developed exclusively for the importing country and as such, Listing /
Registration for the Australian market is not required.”
In the extremely small number of instances (approximately five per year) where an application is
received by the TGA for a product that contains a therapeutic substance not previously evaluated in
Australia, any evidence that the applicant can provide to demonstrate that the substance / product
is approved in the country of destination, or that the importing country has no objection to the TGA
Listing the product for export to that country, is generally considered sufficient to gain export
approval.
Sponsors should also be aware of the following documents pertinent to the export of medicines
available on the TGA website:
Therapeutic Goods Administration (TGA) Policy for the Export of Medicines from Australia
http://www.tga.gov.au/industry/export-medicines-policy.htm
Exporting Medicines from Australia – Operational Guidelines
http://www.tga.gov.au/industry/export-medicines-guidelines.htm
Application for Listing of Export Only Medicines under Section 26 of the Therapeutic Goods Act
1989
http://www.tga.gov.au/about/ebs.htm
Australian Regulatory Guidelines for Complementary Medicines,
Part IV, Section 16 – Medicines for export
V4.2 August 2011
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17. Naming of new
substances and
terminology
This section is divided into the following subsections:
17.1.
What is Australian approved terminology?
17.2.
What are the different types of names for substances?
17.3.
Substances that do not have an approved name
17.1.What is Australian approved terminology?
The Therapeutic Goods Administration (TGA) has developed and maintains lists of Australian
approved terminology for medicines to ensure accuracy and consistency in the information
available to consumers and compiled in the Australian Register of Therapeutic Goods (ARTG).
These lists are published in the TGA Approved Terminology for Medicines and the terms prescribed
in this publication are considered Australian approved terminology. The lists outline the
terminology names for ingredients (active and excipient), containers, dosage forms, routes of
administration and units of expression and proportion.
Australian approved terminology has been developed by the TGA because there is currently no
single internationally agreed list or primary reference available that comprehensively covers all
substances or terms used, or likely to be used, in therapeutic goods in Australia.
Australian approved terminology should be used:

when submitting applications for Registration or Listing of medicines;

in product formulation records included in the ARTG;
on labels, in accordance with the requirements of Therapeutic Goods Order No. 69 – General
requirements for labels for medicines (TGO 69); and

in product information, consumer medicine information (CMI) and other promotional
literature where use of approved terminology is required.
Consistency in naming assists the retrieval of information from the ARTG and the ability of health
professionals and the public to compare similar goods.
The list of Australian Approved Names (AAN) for ingredients in the TGA Approved Terminology for
Medicines has been divided into three sections for ease of reference:

chemical substances;

biological substances - covering substances of biological origin (other than antibiotics) which
are not derived from plants; and

herbal substances – covering substances of plant origin including fungi and blue-green algae.
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Part IV, Section 17 – Naming of new substances and terminology
V4.2 August 2011
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The list gives AANs for substances and cites the authority or reference that uses or defines the
name (e.g. Merck Index). It is intended that the name, together with the reference, will define the
molecular species in the case of a single substance; the composition of the substance in the case of a
mixture; or the characteristics of a variable material.
Use of a reference will depend on common usage and / or the value of the monograph in describing
the name.
Complete details relating to the terminology for medicines is provided in the TGA Approved
Terminology for Medicines.
Sponsors and other users of the list should note the following:

Inclusion of a name in the TGA Approved Terminology for Medicines does not imply any
recommendation for the use of the substance. This document is the source of an approved
name only and it does not mean that the ingredient has been approved for use in Listed
medicines;

The citation of an authority or reference for a name in the list does not imply that the standard
specified by that authority is applicable to the substance used in a particular medicine; and

The list of substances included in the TGA Approved Terminology for Medicines is not a list of
ingredients found in products currently included in the ARTG.
17.2.What are the different types of names for
substances?
AAN – Australian Approved Chemical Substance Name
AANs are allocated to chemical substances. When an application is received for a chemical
substance that is to be used as an excipient in topical products, the excipient may be allocated a
PRV6 status until it has been evaluated for safety. However, that a chemical substance has an ‘AAN’
does not necessarily mean that use of the substance in therapeutic goods has been approved.
ABN – Australian (Approved) Biological Substance Name
ABNs are allocated to biological substances. In addition to the name of the organism, the part,
preparation and / or biological descriptor may be required to fully name a biological substance.
AHN – Australian (Approved) Herbal Name
AHNs are allocated to herbs and are in the Latin binomial format. The name of the species, the part
and the preparation (including solvents and ratio if applicable) are used to fully name a herbal
ingredient.
AHS – Australian (Approved) Herbal Substance
AHS names are allocated to herbal ingredients (e.g. olive oil) that are fully characterised in a
monograph of an accepted pharmacopoeia. 7 While this is the exception to the rule, in the case of
AHSs, the substance must comply with the monograph that is the source of the substance name.
HCN – (Australian Approved) Herbal Component Name
PRV indicates ‘provisional’ status. This means that the ingredient may be included in topical Listed medicines subject
to the provision of certain assurances in relation to safety (refer to ARGCM Part III).
7
Where possible, substance AHSs refer to a monograph in the most recent edition of the British Pharmacopoeia (BP),
European Pharmacopoeia (PH Eur) or the United States Pharmacopoeia (USP) and their supplements. Where there is
no relevant monograph in the most recent edition of the BP, PH Eur or USP, an earlier edition of another suitable
pharmacopoeial reference may be used.
6
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V4.2 August 2011
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HCNs are names for classes of constituents that are found in herbal ingredients. The need for a HCN
most often arises when a herbal extract is standardised to a particular class of constituents, or
where particular classes of constituents are restricted (e.g. hydroxyanthracene derivatives). Where
a herbal extract is standardised to a single constituent, the single constituent should have an AAN
(chemical name). A HCN is not a stand-alone name and should be used only when expressing a
herbal substance.
AFN – Australian (Approved) Food Name
AFNs are allocated to substances (e.g. orange) that are food grade. In addition to the AFN, the full
name of the food ingredient (e.g. orange juice) in the ‘preparation’ is usually required. When using
the AFN for a substance, the ingredient can be used only as an excipient in therapeutic goods. If the
substance is to be included as an active ingredient in a product, the name of the substance should
be expressed in AHN format (e.g. Citrus sinensis fruit juice).
Label-AAN – Australian Approved Label Names
In the case where the name needed to describe a substance (the full AAN) is considered too long to
be mandatory on labels, the TGA may approve an alternative name for use on labels only (a labelAAN). The full AAN would need to be a minimum of 40 characters before a label-AAN would be
considered.
Label-AANs may also be approved for complementary medicine substances where the full AAN is
considered unsuitable for use on labels because consumers may not understand the terminology
used.
Labels may also include Greek symbols (e.g. -tocopherol instead of the AAN alpha tocopherol).
However, as the ARTG is unable to store these symbols, the full AAN must be included in product
applications.
Where an ingredient used in a formulation is a hydrated form and the water of hydration
information is included in the approved name, it is acceptable to include the approved name (and
quantity) of the anhydrous form on product labels.
17.3.Substances that do not have an approved name
17.3.1. Application Forms
When submitting an application for evaluation of a complementary medicine substance, including a
new substance in a Registrable complementary medicine, that does not currently have an AAN,
sponsors will need to submit a proposal for a new AAN with their application.
The seven different application forms are available on the TGA website, as follows:

Application Form for Proposing a Chemical Name (AAN or ADN and chemical PRV)

Application Form for Proposing a Biological Name (ABN and biological PRV) or Term

Application Form for Proposing a Botanical Name for a Herb (AHN and herbal PRV)

Application Form for Proposing a Herbal Substance Name (AHS and herbal substance PRV)

Application Form for Proposing a Herbal Component Name (HCN)

Application Form for Proposing a Plant Food Name (AFN)
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V4.2 August 2011
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
Application Form for Proposing Approved Names(s) be Added to a Label-AAN Group (all name
types).
Specific details of what should be provided with a proposal for a new name are included in each of
the application forms. Proposed Label-AANs for the substance should be included on the
application form. A proposal for a Label-AAN should be accompanied by a justification for its use
and references in support of its use.
Applications are likely to be processed without delay if:

the ingredient name form (the latest edition of the TGA Approved Terminology for Medicines) is
received correctly completed;

the ingredient is defined by a monograph in one (or more) of the references included in the
TGA Approved Terminology for Medicines 1999 edition (pages 11-12 for chemical ingredient
names and pages 162-163 for biological ingredient names);

copies of the relevant monograph(s) are attached to the proposal form;

the monograph defines the name with sufficient precision to enable the committee(s) (see
below) to have confidence that the ingredient so named can be identified.
Note: Copies of product labels are not required to process an AAN application.
Completed forms should be sent to:
AAN Committee / ABN Committee / Herbal Ingredient Naming Committee
c/- Non-Prescription Medicines Branch, Office of Scientific Services
Market Authorisation Group
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606
AUSTRALIA
17.3.2. Review of New AAN Requests
The TGA has established three committees to review applications for new AANs, in order to
accurately identify substances and provide consistency in naming:

Australian Approved Name (AAN) Committee;

Australian Biological Name (AAN) Committee; and

Herbal Ingredient Naming Committee (HINC).
The process for review of new AAN applications is summarised below:
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V4.2 August 2011
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1.
Applications are checked to determine whether the form has been fully completed and
references attached (applications which are not complete will be returned with a request for
more information).
2.
‘Complete’ applications are referred to the appropriate committee for review (committee
members have five working days in which to consider the application).
3.
Committee members meet to review the application and make a decision.
4.
If successful, sponsors will be notified by mail (and TGA eBusiness Services (eBS)) will be
updated to include the new name).
5.
If unsuccessful, sponsors will be notified by mail of the decision and a justification provided as
to why the proposed name is unacceptable. (Sponsors may request that their application be
considered again, if they believe that they have justification to support an alternative to the
committee’s decision.)
The AAN and ABN committees and the HINC attempt to consider and approve (or otherwise)
proposals for new ingredient names within fifteen (working) days from their receipt by the Office
of Scientific Services. However, these time frames are unlikely to be met if insufficient information
is provided in the application.
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V4.2 August 2011
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18. Colourings permitted
in medicines for oral use
A list of colourings permitted in complementary, over-the-counter and prescription medicines for
oral use, and indicative data requirements for the evaluation of new colours (for inclusion in
medicines for oral use), is located at <http://www.tga.gov.au/industry/pm-argpm-guidance22.htm> on the Therapeutic Goods Administration website.
Australian Regulatory Guidelines for Complementary Medicines,
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V4.2 August 2011
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19. Herbal ingredients –
quality
This section is divided into the following subsections:
19.1.
Background
19.2.
Scope of the Guideline for herbal substances
19.3.
General concepts
19.4.
Compositional guideline
19.5.
Herbal preparations
The following information provides general principles on the setting and justification, to the extent
possible, of a compositional guideline for herbal substances.
This information has been adapted from the European Medicines Agency (EMEA) document
entitled Note for Guidance on Specifications: Test Procedures and Acceptance Criteria for Herbal
Drugs, Herbal Drug Preparations and Herbal Medicinal Products (CPMP/QWP/2820/00).
19.1.Background
A compositional guideline is a list of tests, references to analytical and biological procedures, and
appropriate acceptance criteria, which are numerical limits, ranges, or other criteria for the tests
described. It establishes the set of criteria to which a herbal substance should conform to be
considered acceptable for its intended use.
Compositional guidelines for herbal substances are one part of a total control strategy for herbal
medicinal products designed to ensure product quality and consistency.
In the case of herbal medicinal products, compositional guideline requirements are generally
applied to the herbal substance used in the manufacture of the product (includes raw herbal
materials and herbal preparations). Compositional guideline requirements are primarily intended
to define the quality of the herbal substance and should focus on those characteristics found to be
useful in ensuring safety and quality.
19.2. Scope of the Guideline for herbal substances
The quality of herbal medicinal products is determined by the quality of the herbal substance,
development, in-process controls, good manufacturing practice (GMP) controls, and process
validation, and by compositional requirements applied to them throughout development and
manufacture. This guideline addresses compositional guideline requirements, ie. those tests,
procedures, and acceptance criteria used to assure the quality of the herbal substance at the time it
is used in the production of the finished product. Compositional guidelines are an important
component of quality assurance, but are not its only component. All of the considerations listed
above are necessary to ensure consistent production of herbal medicinal products of high quality.
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V4.2 August 2011
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Guidance is provided about acceptance criteria which should be established for all herbal
substances unless otherwise justified. This guideline should not be considered all encompassing.
For example, sponsors should refer to the CHC Code of Practice for Ensuring Raw Material Quality &
Safety (prepared by the Raw Material Suppliers Committee of the Complementary Healthcare
Council of Australia) for general principles relating to the quality of raw materials for use in
complementary medicines.
New analytical technology and modifications to existing technology are continuously being
developed. Such technologies should be used when appropriate.
19.3.General concepts
The following concepts are important in the development and setting of compositional guidelines
for herbal substances. They are not universally applicable, but each should be considered in
particular circumstances. A brief definition of each concept and an indication of the circumstances
under which it may be applicable are given.
19.3.1. Characterisation
Consistent quality of products of herbal origin can be assured only if the starting plant material is
defined in a rigorous and detailed manner. Characterisation of a herbal substance (which includes a
detailed evaluation of the botanical and phytochemical aspects of the plant and manufacture of a
preparation where applicable) is therefore essential to allow establishment of compositional
guidelines that are comprehensive and relevant to safety and quality.
Compositional guidelines should primarily be established and justified based on information from
batches used in establishing safety (including clinical studies) or described in relevant
bibliographic data.
Extensive characterisation is usually performed only in the development phase and where
necessary following significant process changes.
Macroscopical / microscopical characterisation
This type of characterisation includes features that distinguish the active plant from potential
adulterants and substitutes.
Phytochemical characterisation
This covers analytical research of constituents, including active constituents and compounds
suitable as marker substances, and chromatographic fingerprinting.
Potential impurities / contaminants / degradation products
This includes aspects such as toxic elements, pesticides, fumigants etc.
Biological variation
This includes historical batch data and published information about biological variation.
19.3.2. Development considerations
The experience and data accumulated during the development of a new herbal substance should
form the basis for the setting of compositional guidelines. For example, it may be possible to
propose excluding or replacing certain tests on this basis.
Two examples are:
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V4.2 August 2011
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
reduced testing for pesticides residues where a plant is grown under strict organic cultivation
without pesticides etc and potential contamination has been eliminated; and

excluding or reducing tests for microbial limits in herbal extracts or tinctures depending on the
ethanol content if justified by scientific evidence.
19.3.3. Pharmacopoeial tests and acceptance criteria
The British Pharmacopoeia (BP) contains important requirements pertaining to certain analytical
procedures and acceptance criteria that are relevant to herbal substances. Wherever they are
appropriate, pharmacopoeial methods should be used.
19.3.4. Alternative non-pharmacopoeial tests
Alternative tests may be used to measure an attribute if the tests control the quality of the herbal
substance product to an extent that is comparable with or superior to the pharmacopoeial
procedure. However, the pharmacopoeial procedure should still be used to demonstrate
compliance with the compositional guideline (see Subsection 19.4).
19.3.5. Evolving technologies
New technology and modifications to existing technology are continuously being developed. Such
technologies should be used when they are considered to offer additional assurance of quality.
19.3.6. Reference standard
A reference standard, or reference material, is a substance prepared for use as the standard in an
assay, identification, or purity test. In the case of herbal substances, the reference standard may be
a sample of the plant or a chemically defined substance, e.g. a known active constituent, a marker
substance or a known impurity. The composition of reference standards intended for use in assays
should be adequately controlled, and the authenticity or purity of a standard should be determined
by validated procedures.
If the herbal substance is not described in the BP or other recognised monograph, an authenticated
reference specimen (herbarium sample) of the whole plant or a part of the plant should be available
to the manufacturer for authentication. (For more information on the requirements of reference
standards, sponsors should refer to the Therapeutic Goods Administration (TGA) document –
Questions & Answers for the Identification of Herbal Materials and Extracts.)
19.3.7. Statistical concepts
When necessary, statistical analysis should be applied to quantitative data reported.
19.4.Compositional guideline
19.4.1. Definition of compositional guideline
A compositional guideline is defined as a list of tests, references to analytical or biological
procedures, and appropriate acceptance criteria, which are numerical limits, ranges, or other
criteria for the tests described. It establishes the set of criteria to which a herbal substance should
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V4.2 August 2011
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conform to be considered acceptable for its intended use. ‘Conformance to the compositional
guideline’ means that the herbal substance when tested according to the Listed analytical
procedures will meet the Listed acceptance criteria.
It is possible that a compositional guideline requirement may list in-process tests, periodic (skip)
tests, and other tests that are not always conducted on a batch-by-batch basis.
19.4.2. Justification of specifications
Compositional guidelines for herbal materials (mainly whole, unfragmented or cut plants, parts of
plants in an unprocessed state, usually in dry form but sometimes fresh) are linked to:

botanical characteristics of the plant part;

phytochemical characteristics of the plant part – known therapeutic or marker constituents,
toxic constituents (identity, assay, limit tests);

biological / geographical variation;

cultivation / harvesting / drying conditions (microbial levels, aflatoxins, toxic elements etc.);

pre / post-harvest chemical treatments (pesticides, fumigants); and

profile and stability of the constituents.
Compositional guidelines for herbal preparations (obtained by subjecting herbal materials to
certain treatments, such as extraction, distillation etc., consistent with definition of a herbal
substance) are linked to:

quality of herbal material (as above);

method of preparation from the herbal material;

drying conditions (e.g. microbial levels, residual solvents in extracts);

profile and stability of the constituents;

microbial stability; and

batches used in establishing safety of the preparation.
Compositional guidelines should be based on data obtained from lots used to demonstrate
consistency. Linking compositional guidelines to a manufacturing process is important, especially
with regard to process-related constituents and process-related impurities.
Historical batch data should be taken into account where available.
Changes in the manufacturing process, and degradation products produced during storage, may
result in a herbal substance that differs from that used to establish safety. The significance of these
changes should be considered.
19.4.3. Universal tests / criteria
Herbal materials
Herbal materials are a diverse range of botanical materials including leaves, herbs, roots, flowers,
seeds, bark etc. A comprehensive compositional guideline should be developed for each herbal
material, even if the starting material for the manufacture of the finished product is a herbal
preparation (e.g. an extract). In the case of fatty or essential oils used as active substances, a
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compositional guideline requirement for the herbal material is recommended. The requirement
should be established on the basis of recent scientific data.
The general monograph Herbal Drugs of the BP should be consulted for interpretation of the
following guidelines.
The following tests and acceptance criteria are considered generally applicable to all herbal
materials.
Definition: a qualitative statement of the botanical source, plant part used and its state (e.g. whole,
reduced, powdered, fresh, dry). It may also be important to know the geographical source(s) and
the conditions under which the herbal material is obtained.
Characters: a qualitative statement about the organoleptic character(s) where characteristic, and
the macroscopic and microscopic botanical characters of the herbal material.
Identification: identification testing optimally should be able to discriminate between related
species and / or potential adulterants / substitutes that are likely to be present. Identification tests
should be specific for the herbal drug and are usually a combination of three or more of the
following:

macroscopical characters;

microscopical characters;

chromatographic procedures; and / or

chemical reactions.
Tests:

foreign matter;

total ash;

ash insoluble in hydrochloric acid8;

water soluble extractive9; and / or

extractable matter9.
Particle size: For some herbal materials intended for use in herbal teas or solid herbal medicinal
products, particle size can have a significant effect on dissolution rates, bioavailability, and / or
stability. In such instances, testing for particle size distribution should be carried out using an
appropriate procedure, and limit criteria should be provided.
Water content: This test is important when the herbal materials are known to be hygroscopic. For
non-pharmacopoeial herbal materials, criteria should be justified by data on the effects of moisture
absorption. A ‘loss on drying’ procedure may be adequate; but in some cases (essential-oil
containing plants), a detection procedure that is specific for water is required.
Incidental metals and non-metals: The need for tests and acceptance criteria for incidental
metals and non-metals should be studied during development and based on knowledge of the plant
species, its cultivation and the manufacturing process.
Acceptance criteria will ultimately depend on safety considerations. Where relevant, procedures
and acceptance criteria for sulfated ash / residue on ignition should follow pharmacopoeial
precedents; other impurities may be determined by other appropriate procedures, e.g. atomic
absorption spectroscopy.
8
These tests might not all apply to herbal materials.
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Microbial limits: There may be a need to specify the total count of aerobic micro-organisms, the
total count of yeasts and moulds, and the absence of specific objectionable bacteria. The source of
the herbal material should be taken into account when considering the inclusion of other possible
pathogens (e.g. Campylobacter and Listeria species). Microbial counts should be determined using
pharmacopoeial procedures or other validated procedures.
Microbial toxins: The potential for microbial toxin contamination should be fully considered.
Where necessary, validated methods should be used to control potential microbial toxins.
Agricultural and veterinary chemicals etc.: The potential for residues of pesticides, fumigants
etc. should be fully considered. Where necessary, validated methods should be used to control
potential residues. In the case of pesticide residues, the method, acceptance criteria and guidance
on the methodology of the BP should be followed.
Other appropriate tests: 9 (e.g. swelling index).
Assay: In the case of herbal materials with constituents of known therapeutic activity, the content
of the constituents should be assayed. Where possible, a specific, stability-indicating procedure
should be used to determine the content of active constituent in the herbal material. In cases where
a non-specific assay is used, other supporting analytical procedures should also be used to achieve
overall specificity. For example, where determination of essential oils is adopted to assay the herbal
material, the combination of the assay and a suitable test for identification (e.g. fingerprint
chromatography) can be used.
In the case of herbal materials where the constituents responsible for the therapeutic activity are
unknown, appropriate marker substances may be assayed.
19.5.Herbal preparations
Herbal preparations are diverse in character, ranging from simple, comminuted or powdered plant
materials, to extracts, tinctures, essential oils and fatty oils and exudates. A comprehensive
compositional guideline based on recent scientific data should be developed for each herbal
preparation. The general monograph Herbal Drug Preparations of the BP should be consulted for
the interpretation of the following guidelines.
The following tests and acceptance criteria are considered generally applicable to all herbal
preparations:
Definition: a statement of the botanical source, and the type of preparation (e.g. dry or liquid
extract) and the ratio of the herbal material to the herbal preparation.
Characters: a qualitative statement about the organoleptic characters of the herbal preparation
where characteristic.
Identification: Identification tests should be specific for the herbal preparation, and optimally
should be discriminatory with regard to substitutes / adulterants that are likely to occur.
Identification solely by chromatographic retention time, for example, is not regarded as being
specific; however, a combination of chromatographic tests (e.g. high-performance liquid
chromatography (HPLC) and thin-layer chromatography (TLC)-densitometry) or a combination of
tests into a single procedure, such as HPLC / ultraviolet (UV)-diode array, HPLC / mass
spectrometry (MS), or gas chromatography (GC) / MS may be acceptable.
Residual solvents: The BP monograph Residual Solvents can be referred to for detailed
information.
9
These tests might not all apply to herbal materials.
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Water content: This test is important when the herbal preparations are known to be hygroscopic.
The acceptance criteria may be justified with data on the effects of hydration or moisture
absorption. A ‘loss on drying’ procedure may be adequate, but in some cases (essential-oilcontaining preparations), a detection procedure that is specific for water is required.
Incidental metals and non-metals: the need for inclusion of tests and acceptance criteria for
incidental metals and non-metals should be studied during the development, and based on
knowledge of the plant species, its cultivation and the manufacturing process. The potential for the
manufacturing process to concentrate residues should be fully addressed. If the manufacturing
process will reduce the burden or residue, the tests with the herbal material may be sufficient.
Acceptance criteria will ultimately depend on safety considerations. Where relevant, procedures
and acceptance criteria for sulfated ash / residue on ignition should follow pharmacopoeial
precedents; other impurities may be determined by other appropriate procedures, e.g. atomic
absorption spectroscopy.
Microbial limits: The source of the herbal material should be taken into account when considering
the inclusion of other possible pathogens (e.g. Campylobacter and Listeria species).
Sterile Products
The official requirements for sterility tests in Australia are those specified in the current gazetted
edition of the BP. This is the minimum standard with which manufacturers must comply. The
sterility tests published in editions of the BP and Ph. Eur. prior to 1998 are not acceptable.
The TGA Guidelines for Sterility Testing of Therapeutic Goods provide guidance for sterility testing of
sterile therapeutic goods supplied in Australia for human use. These guidelines, however, are not
mandatory for industry.
Generally, products that are required to be sterile (e.g. for ophthalmic use) will require extremely
stringent microbiological specifications together with detailed information on manufacturing steps
that ensure sterility.
Non-Sterile Products
Therapeutic Goods Order No. 77 – Microbiological Standards for Medicines sets out the microbial
limits that apply to non-sterile dosage forms.
All non-sterile dosage forms should include limits for microbial content in the finished product
batch release and expiry specifications. Microbial specifications for solid oral or dry powder
products may not be necessary if their absence can be justified in the application by establishing
during product development that the product is at a very low risk of contamination and microbial
growth is not supported. It is not a requirement that every batch of a product be tested at batch
release. Once it has been demonstrated that the manufacturing processes do not permit
contamination by excessive numbers of microorganisms, by testing a number of routine production
batches to establish a product history, testing could be reduced to once every six to twelve months
or on a selected basis (e.g. every tenth batch).
Products with significant water content (e.g. creams, gels and oral liquids) are likely to support
microbial growth. Such products should include tests and limits for microbial content in both the
batch release and expiry specifications.
For products containing antimicrobial preservatives, both the batch release and expiry
specifications should include physico-chemical tests and limits for content of preservatives. Given
that the effectiveness of many preservatives is pH dependent, the specifications for such products
should usually include requirements for pH that will ensure preservative efficacy. The expiry limits
for the preservative should be supported by preservative efficacy testing that is performed during
stability testing.
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Microbial toxins: The potential for microbial toxin contamination should be fully considered.
Where necessary, validated methods should be used to control potential microbial toxins.
Agricultural and veterinary chemicals etc: the potential for residues of pesticides fumigants etc.
should be fully considered. Where necessary, validated methods should be used to control potential
residues. In the case of pesticide residues the method, acceptance criteria and guidance on the
methodology of the BP should be applied.
Assay: In the case of herbal preparations with constituents of known therapeutic activity, the
content of the active constituents should be assayed. Where possible, a specific, stability-indicating
procedure should be included to determine the content of the active constituent in the herbal
preparation. In cases where use of a non-specific assay is used, other supporting analytical
procedures should also be used to achieve overall specificity.
For example, where a visible UV spectrophotometric assay is used e.g. with anthraquinone
glycosides, a combination of the assay and a suitable test for identification
(e.g. chromatographic fingerprint) can be used. In the case of herbal preparations where the
constituents responsible for the therapeutic activity are unknown, appropriate marker substances
may be assayed.
Guidance on validating analytical test methods can be found in Analytical procedure validation for
complementary medicines.
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20. Ingredients of human
or animal origin
This section is divided into the following subsections:
20.1.
Minimising the risk of transmitting animal spongiform encephalopathy agents via human
and veterinary medicinal products
20.2.
Ingredients of human origin
20.1.Minimising the risk of transmitting animal
spongiform encephalopathy agents via human and
veterinary medicinal products
The purpose of this subsection is to provide further guidance to sponsors and manufacturers for
minimising the risk of carrying transmissible spongiform encephalopathy (TSE) agents in
therapeutic goods. These assessment practices are in accordance with guidance developed by the
European Union (EU).
This document complements the guidance document developed in the EU by the Committee for
Medicinal Products for Human Use (CHMP) Note for Guidance on Minimising the Risk of
Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal
Products (EMEA/410/01 Rev 2) and its subsequent revisions by the European Medicines
Evaluation Agency (EMEA). The CHMP guidance has been adopted by the TGA as the basis for
managing TSE risks in therapeutic goods.
The Therapeutic Goods Administration (TGA) document Supplementary Requirements for
Therapeutic Goods for Minimising the Risk of Transmitting Transmissible Spongiform
Encephalopathies (TSEs) is available at <http://www.tga.gov.au/industry/tse-supplementaryrequirements.htm> on the TGA website. The document focuses on ingredients of human and animal
(particularly ruminant) origin that are currently classified in Category C of the CHMP Guidance; that
is, those ingredients characterised as having no detectable infectivity according to current
knowledge of TSE transmission. The supplementary requirements propose that Category C
ingredients should be allowed for use in the preparation of active or excipient substances or as raw
or source materials, or reagents in their production.
Sponsors must self-assess Category C materials according to the requirements. A questionnaire has
been provided to aid sponsors in obtaining information from suppliers. The TSE questionnaire for
sponsors can be downloaded from <http://www.tga.gov.au/industry/tse-sponsorquestionnaire.htm>.
This questionnaire has been designed by the TGA in consultation with Australian industry bodies to
facilitate the collection of data to enable sponsors to self-certify their therapeutic goods against the
TGA’s Supplementary Requirements for Therapeutic Goods for Minimising the Risk of Transmitting
Transmissible Spongiform Encephalopathies (TSEs). The questionnaire should be sent to suppliers
and manufacturers to obtain information about materials of ruminant origin used in the
manufacture of raw materials, active ingredients, excipients, device components, reagents and
finished products.
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If the ingredients are sourced from countries with a high risk of TSE (as per appendix 3 of the TGA’s
TSE guidance document) or from countries with low-moderate risk of TSE where the material is not
one of the following:

hide-derived gelatine;

bone-derived gelatin (excluding vertebrae);

wool derivatives, tallow derivatives or milk; and

derivatives (produced without the use of rennet / other ruminant materials)
then clearance for use of the ingredient will have to be obtained from the TGA.
Applications for clearance of ingredients of animal origin can be completed online
(<http://www.tga.gov.au/industry/cm-forms-animal-derived-ingredients.htm>) and should be
directed to:
Administrative Officer
Pathogen Safety Section
Biological Science Unit Blood and Tissues Unit
Office of Scientific Evaluation
Market Authorisation Group
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606.
Initial information should provide:

the product’s identification;

the name of the ingredient(s) of animal origin;

any pharmacopoeial reference applicable to the ingredient;

the quantity of the ingredient per dose unit;

the name of the animal species;

the name of the body part; and

the country of origin of the animal.
This information will enable the Office of Scientific Evaluation (OSE) to determine whether more
information is required. If the screening demonstrates that the product could pose a risk of slow
virus transmission, details of additional data requirements will be advised.
Any material of animal (ruminant) origin that is not highly processed (e.g. blood, enzymes) should
be submitted to the OSE for pre-clearance.
20.2.Ingredients of human origin
If the material is of human origin, sponsors should first contact the Head of the OSE for details of
data requirements.
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21. Glossary of terms
used in the Australian
Regulatory Guidelines for
Complementary Medicines
This document contains interpretations of terms commonly used by the Therapeutic Goods
Administration (TGA) in regard to medicines and identifies terms which are defined in the
Therapeutic Goods Act 1989 and Therapeutic Goods (Charges) Act 1989 and the Therapeutic Goods
Regulations 1990.
This glossary is not exhaustive and does not include many terms that are ‘technically’ specific to
only some areas of TGA; in particular, it does not interpret terms, which are used exclusively for, or
in connection with the manufacture of prescription medicines or therapeutic devices.
Terms which are defined in the Acts and their Regulations may be defined slightly differently (e.g.
to expand or narrow a definition) in Therapeutic Goods Orders made under the Act. References
should be made to the definitions in the relevant Order when determining the requirements of a
standard such as those for the labelling of medicines.
This document includes terms used only in relation to medicines. It does not include terms related
only to medical devices.
21.1.Notes
1.
Defined in the Therapeutic Goods Act 1989 in subsection 3(1) unless another Section of the
Act is indicated
2.
Defined in the Therapeutic Goods Regulations 1990 in Regulation 2 unless another regulation
number is indicated
3.
Defined in the Therapeutic Goods (MD) Regulations 2002 in Regulation 1.3 unless another
regulation number is indicated
4.
Defined in the Therapeutic Goods (Charges) Regulations 1990 in Regulation 2 unless another
regulation number is indicated
*
Relates only to drug products – Medicine Regulations
21.2.Glossary
Acceptable country2*
A country that the Minister has notified in the Gazette as an acceptable country for the purposes of
this regulation. (Regulation 16C)
Act4
The Therapeutic Goods Act 1989.
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Active ingredient1, 2*
The therapeutically active component in a medicine’s final formulation that is responsible for its
physiological action.
Active pharmaceutical ingredient (API)
Therapeutically active component in the final formulation of therapeutic goods.
Active raw material
The unformulated active chemical substance, usually a powder or a liquid, in the form in which it is
used to manufacture a dosage form, usually in combination with excipients.
Actual or potential tampering1
a.
b.
c.
d.
tampering with the therapeutic goods; OR
causing the therapeutic goods to be tampered with; OR
proposing to tamper with the therapeutic goods; OR
proposing to cause the therapeutic goods to be tampered with.
(Section 42U)
Advertisement1
In relation to therapeutic goods, advertisement includes any statement, pictorial representation or
design, however made, that is intended, whether directly or indirectly, to promote the use or supply
of the goods.
Agent
A person duly authorised in writing to act on behalf of the sponsor of the goods.
AHMAC
The Australian Health Ministers’ Advisory Council and subcommittees of the Council acting on its
behalf.
Analysis2
Includes examination and testing.
Animal3
An invertebrate or vertebrate member of the animal kingdom.
Antibiotic
A selective antimicrobial agent, other than disinfectants, antiseptics and substances used solely as
antineoplastics, that, on application to living tissue or by systemic administration, kills or prevents
the growth of susceptible micro-organisms.
Appellant
In the terms of the Therapeutic Goods Act 1989 – a person seeking a review of a decision under the
provisions of Section 60 of the Act or Regulation 48 of the Regulations to the Act. (Section 60)
Applicant2
In relation to advertisements for therapeutic goods, means an applicant for approval of an
advertisement. (Section 5B)
In relation to Part 3, division 4, means an applicant of the use of a restricted representation in an
advertisement about therapeutic goods. (Regulation 6AA)
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Application
An application made to TGA under the following sections of the Therapeutic Goods Act 1989 (note
that where the Section / Regulation number is highlighted, the word ‘application’ is used in the
legislation):

Section 14 (exemption from compliance with a Standard);

Section 19 and 41HB (special and experimental uses); and

Section 23, 24, 25 and 26 (Registration or Listing)
[Note that each application results in a single Registration or Listing or the inclusion of a separate
and distinct product within a grouped Registration or Listing]; or

Section 9C (request for copy of ARTG entry)

Section 9D (request to vary information about an ARTG entry)

Section 37 and 38 (manufacturer’s licence)

Section 41EB (conformity assessment certificates)

Section 58 (export certification)

Section 61(6) (information from ARTG)

Regulation 14 (transfer of goods Registered / Listed)

Regulation 14A (reassignment of Registration / Listing numbers).
(See also Submission.)
Approval holder2
In relation to a restricted representation, means the person to whom notice of approval of the use
of the restricted representation was given. (Regulation 6AA)
Approval number1
The distinguishing number allocated to an approved advertisement by the Secretary under
Regulation 5J of the Therapeutic Goods Regulations 1990. (Section 42B)
Approved advertisement1, 2
An advertisement which is approved under regulation 5G, or taken to be approved by the Secretary
under Sub regulation 5H(2), or approved by the Minister on review under regulation 5M, of the
Therapeutic Goods Regulations 1990 and the approval has not been withdrawn. (Section 42B)
Approved type3
A type that has been examined and approved by the Secretary under the type examination
procedures.
ARTG
Australian Register of Therapeutic Goods.
ARTG entry
Refers to a separate and distinct product included in the ARTG, as described by the criteria in
subsection 16(1) of the Therapeutic Goods Act 1989. Grouped products represent two or more
ARTG entries under a single ARTG number.
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ARTG purpose
Relates to the basis for inclusion of the goods in the ARTG. Goods are included in the Register as a
mechanism indicating approval for supply in Australia and / or approval for export from Australia.
Goods Listed for export will have an ARTG purpose of ‘export’ only, all others will have a purpose of
‘supply’.
ARTG status
A term which describes the Registration / Listing status of therapeutic goods in relation to their
inclusion, or otherwise, in the ARTG. It includes Registered, Listed, cancelled by Secretary and
cancelled by sponsor.
ASMI2
The Australian Self-Medication Industry Incorporated (ABN 55 082 798 952).
AUST L
See Listing number.
AUST R
See Registration number.
Australian Approved Name (AAN) for pharmaceutical substances
A name for an ingredient, or a plant or other organism included in the formulation of a medicinal
product, which is included in the list of Australian Approved Names for Pharmaceutical Substances
published by the TGA. The list comprises three parts:

AAN chemical substances list;

AAN biological substances list; and

AAN herbal substances list.
(See TGA Approved Terminology for Drugs.)
Australian Approved Names List2
The document entitled TGA Approved Terminology for Medicines (July 1999), as in force from time
to time, published by the TGA.
Note 1
The Australian Approved Names List includes:
a.
b.
c.
Note 2
Australian Approved Names – Chemicals List; and
Australian Approved Names – Biologicals List; and
Australian Approved Names – Herbal Substances List.
The Australian Approved Names List may be published as part of a larger document; for
example, the document entitled TGA Approved Terminology for Medicines.
Australian legal unit of measurement3
Has the meaning given by the National Measurement Act 1960.
Authorised delegate
A delegate of the Secretary exercising a power to decide whether to Register therapeutic goods.
(Section 60A(8))
Authorised officer2
An officer of the Department, or of another Department or authority of the Commonwealth; or an
officer of:
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i.
ii.
iii.
a Department of State of a State;
a Department or administrative unit of the Public Service of a Territory;
an authority of a State or Territory
that is a Department, unit or authority the functions of which relate to health matters; who is
authorised in writing by the Secretary to exercise powers under that Provision. (Regulation 23)
Note: may also refer to persons authorised to examine records of the importation of therapeutic
substances in accordance with regulation 5A of the Customs (Prohibited Imports) Regulations or to
persons authorised to grant import permission for goods listed in Schedule 8 of the Customs
(Prohibited Imports) Regulations.
Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers
under that provision.
Authorised person1, 2, 3
In relation to any provision of the Act, a person authorised by the Secretary to exercise powers
under that provision; or in relation to a provision of Part 6-2, a member of the Australian Federal
Police or a Customs officer exercising powers in a Customs place (within the meaning of Section
183UA of the Customs Act 1901).
Note: may also refer to person authorised to grant import permission for therapeutic substances
under regulation 5A of the Customs (Prohibited Imports) Regulations.
Batch1
A quantity of a product that is;
a.
b.
uniform in composition, method of manufacture and probability of chemical or microbial
contamination; and
made in one cycle of manufacture and, in the case of a product that is sterilised or freeze
dried, sterilised or freeze dried in one cycle.
Bioburden1
The quantity and characteristics of micro-organisms present in the goods or to which the goods
may be exposed in a manufacturing environment.
Biologic4
In relation to therapeutic goods, a good in which the active ingredient is a biological substance.
Biological products
Products in which the active ingredient is a biological substance including antisera, antivenins,
monoclonal antibodies and products of recombinant technology.
Biological substance4
Substances of biological origin, which are frequently chemically complex and have molecular
weights over 1000, such as hormones, enzymes and related substances, but not including herbal
substances and antibiotics. Biological substances are not uniquely defined by a chemical name
because their purity, strength and composition cannot readily be determined by chemical analysis.
Substances which can be isolated as a low molecular weight pure substance, such as purified
steroids, digoxin and ergotamine, are considered to be chemical substances.
Body orifice3
A natural opening, or a permanent artificial opening, in a human being’s body; includes the external
surface of a human being’s eyeball.
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British Pharmacopoeia1
The edition of the book of that name, including any additions or amendments, that was in effect for
the purposes of the Therapeutic Goods Act 1989 (the Act)immediately before the commencement of
this section and, if additions or amendments of that book are made after that commencement, or
new editions of that book are published after that commencement, includes those additions or
amendments, or those new editions, from the day specified by the Minister by order published in
the Gazette.
Broadcaster
In relation to an advertisement for therapeutic goods, means a person (other than a person who is
required to enter those goods on the Register) who undertakes, as a business activity in its own
right:
a.
b.
the broadcasting of the advertisement in broadcast media; OR
the placement of the advertisement for such broadcasting.
(Section 42B)
Broadcast media
In relation to an advertisement or generic information, means any means (other than a means
declared in the regulations to be an exempted means) by which the information is disseminated
electronically in a visible or audible form or a combination of such forms. (Section 42B)
Business name
The name of the person or corporation for which particulars are being supplied or which is making
an application. It may be either the name Registered with the Australian Securities Commission, or
the name of the person or persons who conduct the business. Trading names are not usually
included in the business name for Australian applicants, but may be supplied in particular for
overseas companies. Also referred to as client name / ID. (See also Client)
Certified product details (CPD)
A statement of product details, specifications and test methods generated by the sponsor at the
request of the TGA.
CHC2
The Complementary Healthcare Council of Australia.
Charge
The sum payable annually for activities identified under the Therapeutic Goods (Charges) Act 1989
(e.g. Registration, Listing and manufacturing licence).
Client
A person or organisation having an involvement in the import, export, manufacture or supply of
therapeutic goods. An enterprise can include sponsors, manufacturers and agents.
Client identification code (Client ID)
Identification code assigned by the TGA to a client.
Clinical trial
A planned study in humans designed to investigate or report upon the effectiveness and / or safety
of a therapeutic good. (See experimental purposes in humans.)
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Committee1, 2
A number of committees are defined in the Therapeutic Goods Act 1989 (the Act) and the
Therapeutic Goods Regulations 1990 (the Regulations):

Therapeutic Goods Committee – Regulation 34 of the 1990

Advisory Committee on Prescription Medicines – Regulation 35 of the Regulations

Advisory Committee on the Safety of Medicines – Regulation 37 of the Regulations

Advisory Committee on Non-prescription Medicines – Regulation 36 of the Regulations

Advisory Committee on Complementary Medicines – Regulation 39 of the Regulations

Advisory Committee on Medicine Scheduling – Section 52B of the Act and Regulation 42ZCA of
the Regulations.

Therapeutic Goods Advertising Code Council – Regulation 42A of the Regulations

Complaint’s Resolution Panel – Regulation 42R of the Regulations

Advisory Committee on Medical Devices – Regulation 38 of the Regulations.
Commonwealth authority1
A body corporate, or an unincorporated body, established for a public purpose by or under an Act;
or a tribunal or authority established by or in accordance with an Act.
Commonwealth officer1
a.
a Minister
b.
a person holding:
i.
ii.
iii.
an office established by or under an Act
an appointment made under an Act
an appointment made by the Governor-General or a Minister but not under an Act
c.
a person who is a member or officer of a Commonwealth authority
d.
a person who is in the service or employment of the Commonwealth or engaged under an Act
or regulations made under an Act.
Complaint2
In relation to Part 6, Division 3, subdivision 2 of the Regulations, means a complaint about an
advertisement of generic information made to the Complaints Resolution Panel (CRP) in
accordance with Regulation 42ZCAB of the Therapeutic Goods Regulations 1990.
Complaints Resolution Panel2
The panel established under Regulation 42R of the Therapeutic Goods Regulations 1990.
Advisory Committee on Complementary Medicines (ACCM)2
The committee established under Regulation 39 of the Therapeutic Goods Regulations 1990.
Composite pack1
A medicinal product where the primary pack or the container includes at least two kinds of
medicinal products and does not contain any medical devices. The medicinal products must be for
use as a single treatment or as a single course of treatment, and it is necessary that the medicines
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be combined before administration or that they must be administered in a particular sequence.
(Section 7B(2)).
Examples include:

a strip or blister pack containing tablets or capsules with differing formulations to be taken in a
specified order

a primary pack containing an active ingredient in one vial and a diluent in another vial

a primary pack containing separate containers of different formulations for use as part of a
single regimen of treatment.
Consumer Medicine Information (CMI)
Document required to be provided to patients with Schedule 10 medicines Registered on the
Australian Register of Therapeutic Goods on or after 1 January 1993. It provides patients with a
‘plain English’ explanation of the product. (See also Product information and Patient information
document.)
Container1
The vessel, bottle, tube, ampoule, syringe, vial, sachet, strip pack, blister pack, wrapper, cover or
other similar article that immediately covers the goods, but does not include an article intended for
ingestion. (See also Primary pack.)
Container type
The Act describes a container as a ‘vessel, bottle, tube, ampoule .... or other similar article that
immediately covers the goods ...’. Types of containers are defined in the TGA list Types of Containers
published in the latest edition of TGA Approved Terminology for Drugs. It describes container types
for the purposes of Subsection 16(1)(g) of the Therapeutic Goods Act 1989. Container types are
independent of the material used to make them.
Contract manufacture
Where all or part of the manufacturing process of therapeutic goods is carried out on a contract
basis by a person other than the sponsor. Can include principal manufacturers and other
(sub)manufacturers.
Corporation1
A body corporate that is:
a.
b.
a foreign corporation OR
a trading corporation formed within the limits of the Commonwealth or a financial
corporation so formed.
Corresponding State law1
A State law declared by the regulations to correspond to the Therapeutic Goods Act 1989 or the
Therapeutic Goods Regulations 1990, including such a law as amended from time to time.
(Regulation 3)
Counterfeit1
Therapeutic goods which contain false representations in the label or presentation of the goods,
any document or record relating to the goods or their manufacture or in any advertisement for the
goods. (Section 42E)
Current Poisons Standard1
The documents prepared in accord with Section 52A. (Section 52A)
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Customs Officer
An officer of Customs within the meaning of the Customs Act 1901.
Data-processing device1
Any article or material (e.g. a disc) from which information can be reproduced with or without the
aid of any other article or device.
Decision
Has the same meaning as in the Administrative Appeals Tribunal Act 1975. (Section 60(1), Regulation
48)
Delegate
An officer who has been given authority by the Minister or Secretary to exercise a power that the
Act or Regulations confer on the Minister / Secretary. (Section 57, Regulation 47 and Regulation
47A).
Designated active ingredient
An active ingredient, or a kind of active ingredient, mentioned in Schedule 14 to the Therapeutic
Goods Regulations 1990.
Designated therapeutic goods2
Therapeutic goods other than:
a.
b.
c.
therapeutic devices
goods included in Schedule 3 to the Poisons Standard that are not included in Appendix H of
that statement
goods included in Schedule 4 or 8 to the Poisons Standard.
Directions for use1
Includes information on:
a.
b.
c.
d.
appropriate uses of the therapeutic goods
the method of administration or use of the goods
the frequency and duration of treatment for each indication of the goods
the use of the goods by persons of particular ages or by persons having particular medical
conditions.
Dosage form
The pharmaceutical form in which a product is presented for therapeutic administration, e.g. tablet,
cream. A list of dosage forms and their definitions for the purposes of recording information in the
Australian Register of Therapeutic Goods is included in the TGA Approved Terminology for Drugs.
Drug
See Medicine. Note that legislative definitions apply in both singular and plural forms.
Engage in conduct
To do an act or to omit to perform an act. (Section 6AA(3A), Section 22(3A) and Section 35(3))
Enterprise
A person or organisation having an involvement in the import, export, manufacture or supply of
therapeutic goods. An enterprise can include sponsors, manufacturers and agents.
Enterprise name
See Business name.
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Ethics committee1
A committee:
a.
b.
constituted and operating as an ethics committee in accordance with guidelines issued by
the National Health and Medical Research Council under the National Health and Medical
Research Council Act 1992
which has notified its existence to the Australian Health Ethics Committee established
under the National Health and Medical Research Council Act 1992.
Evidential material
a.
b.
c.
any thing with respect to which an offence against the Therapeutic Goods Act 1989 has been
committed or is suspected, on reasonable grounds, to have been committed, OR
any thing as to which there are reasonable grounds for suspecting that it will afford
evidence as to the commission of any such offence, OR
any thing as to which there are reasonable grounds for suspecting that it is intended to be
used for the purpose of committing any such offence.
(Section 45A)
Excipient
Any component of a finished dosage form other than an active ingredient (in some cases the
distinction between an active ingredient and an excipient may not be clear cut, e.g. use of sodium
chloride to adjust tonicity of an injection is an excipient).
Excluded goods
Goods which might be considered to be therapeutic goods but which are specifically declared not to
be by an Order of the Secretary (and therefore not subject to any requirements of the Therapeutic
Goods Act 1989). (Section 7)
Exempt goods1
Therapeutic goods that are exempted from the requirements to be Registered or Listed, or are
exempted from licensing requirements by the Therapeutic Goods Regulations 1990.
(Part 3-2)
Exempt person1
A person exempted by the Therapeutic Goods Regulations 1990 from the operation of Part 3-3 in
relation to exempt goods.
Experimental purposes in humans
As used in the Act and Regulations, refers to use of drugs or devices in clinical trials subject to
approval under Section 19(1)(b) of the Therapeutic Goods Act 1989 or to notification under item 3
of Schedule 5A of the Therapeutic Goods Regulations 1990.
Expiry date2
The date (expressed as the month and year) after which the goods should not be used.
Export certification
Can include a WHO Certificate of a Pharmaceutical Product for drugs, a Certificate of Free Sale
(Devices) or an Export Certificate (Devices). (Section 58)
Export name
The proprietary name used for the goods for supply in another country where that name is
different from the proprietary name used for the goods for supply in Australia.
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Export only medicine1
A medicine that:
a.
b.
is manufactured in Australia for export only, or imported into Australia for export only
is Listable goods only because it is so manufactured or imported (and not for any other
reason).
Fee
A sum payable for activities or events identified in Schedule 9 of the Therapeutic Goods Regulations
1990 (e.g. evaluation fee).
Financial corporation1
A financial corporation within the meaning of paragraph 51(xx) of the Constitution.
Finished goods
The finished or final dosage form of the therapeutic good when all stages of manufacture, other
than release for sale, have been completed.
First Poisons Standard1
The latest edition of the document known as the Standard for the Uniform Scheduling of Medicines
and Poisons published by the Australian Government under the Therapeutic Goods Act 1989.
(Section 52A)
FOI Act
The Freedom of Information Act 1982.
Foreign corporation1
A foreign corporation within the meaning of paragraph 51(xx) of the Constitution.
Formulation
A list of the ingredients used in the manufacture of a dosage form and a statement of the quantity of
each ingredient in a defined weight, volume, unit or batch.
For the Australian Register ofTherapeutic Goods database, the recorded formulation excludes
ingredients not present in the finished goods (e.g. water in lyophilised powders), and excludes
overages. Where ingredients used in the manufacture of a dosage form react chemically with one
another, the ingredient formed as a result of this reaction is recorded, not the original ingredients.
Gazette
Commonwealth Government Notices Gazette (published by the Attorney-General’s Department).
Gazetted therapeutic goods group1*
A group of medicines which have common characteristics, that are identified in an order published
in the Gazette. (Subsection 16(2))
Generic information2
In relation to therapeutic goods, it includes any statement, pictorial representation or design,
however made, about the composition, properties or other characteristics of therapeutic goods, but
does not include:
a.
b.
c.
an advertisement about the goods
generic information included in an advertisement about therapeutic goods
bona fide news.
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Generic medicine2
A medicine that, in comparison to a Registered medicine:
a.
b.
c.
d.
has the same quantitative composition of therapeutically active substances, being
substances of similar quality to those used in the Registered medicine
has the same pharmaceutical form
is bioequivalent
has the same safety and efficacy properties.
Gene Technology Regulator1
Has the same meaning as is defined in the Gene Technology Act 2000.
Genetically modified (GM) product1
Has the same meaning as is defined in the Gene Technology Act 2000.
Good manufacturing practice (GMP)
The acronym GMP is used internationally to describe a set of principles and procedures which,
when followed by manufacturers of therapeutic goods, helps ensure that the products
manufactured will have the required quality. A basic tenet of GMP is that quality cannot be tested
into a batch of product but must be built into each batch of product during all stages of the
manufacturing process.
Good manufacturing practice (GMP) Code
A code of principles and practices to be followed in the manufacture of therapeutic goods to
provide assurance of product quality and compliance with product Registration or Listing on the
Australian Register of Therapeutic Goods.
Grouped therapeutic goods1
Therapeutic goods included in:
a.
b.
c.
a gazetted therapeutic goods group; or
a gazetted therapeutic devices group; or
a gazetted kits group.
Grouping
The mechanism whereby goods, which would normally need to be included in the Australian
Register of Therapeutic Goods (ARTG) under different ARTG Registration or Listing numbers
(because they are ‘separate and distinct by virtue of Subsection 16(1) of the Therapeutic Goods Act
1989 (the Act)), may be included in the ARTG under the one ARTG Registration or Listing number,
thereby attracting a single annual charge for the group of goods. Each product (as defined by
Subsection 16(1)) is still regarded as a separate ARTG entry and all controls under the Act apply
discretely to each separate and distinct product (e.g. application fees, conditions, cancellation).
Health professional3
Includes a person who is a medical practitioner, a dentist or any other kind of healthcare worker
Registered under a law of a State or Territory; or a biomedical engineer, chiropractor, optometrist,
orthodontist, osteopath, pharmacist, physiotherapist, podiatrist, prosthetist or rehabilitation
engineer.
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Herbal substance2
All or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):
a.
b.
that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting,
mixing with an inert diluent substance or another herbal substance or mixing with water,
ethanol, glycerol or aqueous ethanol
that is not subjected to any other treatment or process other than a treatment or process
that is necessary for its presentation in a pharmaceutical form.
Homoeopathic preparation2
A preparation:
a.
b.
formulated for use on the principle that it is capable of producing in a healthy person
symptoms similar to those which it is administered to alleviate
prepared according to the practices of homoeopathic pharmacy using the methods of
i.
ii.
serial dilution and succussion of a mother tincture in water, ethanol, aqueous ethanol
or glycerol OR
serial trituration in lactose.
Indications1
The specific therapeutic uses of therapeutic goods.
Individual patient data1
In relation to therapeutic goods, individual patient data means information, derived from clinical
trials, relating to individuals before, during and after the administration of the goods to those
individuals, including but not limited to, demographic, biochemical and haematological information.
(Section 24)
Informed consent2
In relation to treatment or proposed treatment, means consent freely given by a person on the basis
of information concerning the potential risks and benefits of the treatment that was sufficient
information to allow the person to make an informed decision whether to consent to the treatment.
(Regulation 12A)
Initial decision1, 2
Refers to decisions of the Secretary (or authorised delegate) under various sections of the
Therapeutic Goods Act 1989 and Therapeutic Goods Regulations 1990. (Section 60(1) and Regulation
48)
International instrument1
A treaty, convention, protocol, agreement or other instrument (or part thereof) that is binding in
international law.
Jurisdictional member2
A person on a committee who has been nominated under subsection 52B(3) of the Therapeutic
Goods Act 1989 or a person appointed as a representative under paragraph 42ZCD(4)(c) or (d).
(Regulation 42CE)
Kit1
Section 7B(1) describes a kit for the purposes of the Therapeutic Goods Act 1989. Kits are listed as
either medicine or device kits.
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Label1
A display of printed information:
(a)
on or attached to the therapeutic goods OR
(b) on or attached to a container or primary pack in which the goods are supplied OR
(c)
supplied with such a container or pack.
Licence1
A licence under Part 3-3 of the Therapeutic Goods Act 1989.
Licence number
The number of the licence issued by the TGA to a manufacturer of therapeutic goods for use in
humans under Part 4 of the Therapeutic Goods Act 1989.
Listable goods1
Therapeutic Goods that are required, under Schedule 4 of the Therapeutic Goods Regulations 1990
or required by a notice published in the Gazette under subsection 17(5), to be included in that part
of the Australian Register of Therapeutic Goods relating to Listed goods.
Listed goods1
Therapeutic goods that are included in the part of the Australian Register of Therapeutic Goods for
goods known as Listed goods.
Listing number1
Any combination of number, symbols and letters assigned to Listed goods under Section 27 of the
Therapeutic Goods Act 1989. When printed on a label it must be positioned in accordance with the
requirements of Regulation 15 of the Therapeutic Goods Regulations 1990 and preceded by “AUST
L”.
Mainstream media
Any magazine or newspaper for consumers containing a range of news, public interest items,
advertorials, advertisements or competitions. (Section 42B)
Manufacture1*
The production of medicines or any part of the process of producing medicines or bringing the
goods to their final state, including engaging in the processing, assembling, packaging, labelling,
storage, sterilising, testing or releasing for supply of the goods or of any component or ingredient of
the goods as part of that process.
Manufacturer
Corporation or person carrying out one or more of the steps specified in the definition of
manufacture.
Manufacturing licence
A licence granted under Part 3-3 of the Therapeutic Goods Act 1989, or a licence granted under a
State or Territory law relating to therapeutic goods, relating to manufacturing therapeutic goods.
Manufacturing premises1
Premises (including premises that comprise two or more sites):
a.
b.
that are for use in the manufacture of a particular kind of therapeutic goods
at which the same persons have control of the management of the production of the goods
and the procedures for quality control.
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Manufacturing principles1
The principles for the time being having effect under Section 36 of the Therapeutic Goods Act 1989.
This includes codes of Good Manufacturing Practice (GMP).
Medical practitioner1, 3
A person who is registered, in a State or Territory, as a medical practitioner.
(Section 19(9) and Section 41HC(7))
Medicine1*
Medicines are:
a.
b.
therapeutic goods that are represented to achieve, or are likely to achieve, their principal
intended action by pharmacological, chemical, immunological or metabolic means in or on
the body of a human or animal
any other therapeutic goods declared by the Secretary, for the purposes of the definition of
therapeutic device, not to be therapeutic devices.
Previously referred to as drugs.
Medicinal component
The name applied by the Australian Register of Therapeutic Goods to any one item within a
composite pack.
Medicinal product
An alternative term to medicine for the finished, packaged goods.
Medicines Regulations
The Therapeutic Goods Regulations 1990.
Member of European Community1
A country declared by the Minister under Section 3A of the Therapeutic Goods Act 1989 to be a
member of the European Community.
Mother tincture2*
A product of the process of solution, extraction or trituration, from which homoeopathic
preparations are made.
Mutual Recognition Convention1
The convention for the Mutual Recognition of Inspections in respect of the Manufacture of
Pharmaceutical Products, which was agreed at Geneva on 8 October 1970.
Name
As used in relation to differentiation between therapeutic goods in Section 16 of the Therapeutic
Goods Act 1989 may include the brand name, a descriptor of the goods or generic name, together
with a sponsor’s name or logo, or a banner name of a product range, i.e. all elements which,
together, serve to make the product recognisable as a particular item of commerce or supply.
Name of the goods
As defined by the Therapeutic Goods Order No. 69 - General Requirements for Labels for Medicines,
the non-proprietary name, including the name of the dosage form or a synonym for the name of the
dosage form, used to describe the goods in a specific standard. Listing and Registration names
include the name of the goods but may include further information to differentiate between forms of
presentation.
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National Manager of the Therapeutic Goods Administration1
The person holding the position of National Manager of the Therapeutic Goods Administration or, if
the position of National Manager ceases to exist or ceases to exist by that name, the person holding
a position determined in writing by the Secretary.
New information
Information that:
a.
b.
c.
was in existence at the time a decision referred to in subsection (1) was made
was not made available to the Secretary or authorised delegate for the purpose of making
the decision
is relevant to that decision
and includes any opinions that are wholly or substantially based on such information (whether or
not the opinions were formed before or after the decision was made).
(Section 60A(8))
NFAA2
Nutritional Foods Association of Australia.
Non-proprietary name
The name used to describe the goods (particularly medicines) in a specific standard. It includes the
name of the dosage form. If no standard exists, a name may comprise the Australian Approved
Name (AAN) of the active ingredient and the name of the dosage form.
Notification
Advice to the Therapeutic Goods Administration in accordance with the requirements of:

Section 29A (information about Registered goods different from previously given); OR

Section 29B (adverse effects of goods—Registration application withdrawn); OR

Section 9D (variation to goods which may be notified as specified in guidelines); OR

Schedule 5A item 3 (clinical trial); OR

Regulation 13 (change in sponsorship); OR

Regulation 21 (change in QC manager—licensed premises); OR

Regulation 22 (change of licence holder).
Occupier
In relation to premises, includes a person present at the premises who is in apparent control of the
premises. (Section 45A)
Official analyst2
A person approved by the Secretary under Regulation 25 of the Therapeutic Goods Regulations
1990.
Official sample
A sample of goods taken under the provisions of Part 5 of the Therapeutic Goods Regulations 1990.
A certificate of official analyst is issued.
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Open shelf life2
For therapeutic goods, means the time, from when the container holding the goods is opened, after
which the goods should not be used.
Oral
Taken through the mouth into the gastrointestinal system.
OTC medicines2
Over-the-counter medicines. Therapeutic goods mentioned in Part 3 of Schedule 10 of the
Therapeutic Goods Regulations 1990.
Pack size
The size of the goods in terms of the quantity contained in the container (e.g. volume in a multi-use
container) and / or the number of items in the primary / unit pack (e.g. number of tablets in a
bottle).
Partially processed goods
Therapeutic goods whose manufacture has not been completed to the stage of final packaging and
labelling.
Patient information document
A drug information document as described in Schedule 12 to the Therapeutic Goods Regulations
1990, for supply to patients; must be available for certain drugs as specified in Regulation 9A (see
also Consumer Medicine Information).
Person apparently responsible2
In relation to a complaint about an advertisement or generic information, means the person who,
based on the complaint and the assessment of the Complaints Resolution Panel (CRP), appears to
be responsible for requesting the publication or insertion of the advertisement or generic
information in specified media. (Regulation 42ZCAA)
Pharmaceutical benefit2
A Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’
Entitlements Act 1986.
Poison1
An ingredient, compound, material or preparation the use of which may cause death, illness or
injury. Includes any ingredient, compound, material or preparation referred to in a schedule to the
current Poisons Standard.
Poisons Schedule
A schedule of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP).
Poisons Standard2
Has the same meaning as Current Poisons Standard.
Premises1
Includes:
a.
b.
c.
a structure, building, aircraft, vehicle or vessel;
a place (whether enclosed or built upon or not); and
a part of a thing referred to in items (a) or (b).
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Prescribed quality and safety criteria
Quality and safety requirements referenced in the Therapeutic Goods Regulations 1990 for
particular Listable goods or categories of Listable goods. (Section 26(1)(k))
Presentation1
The way in which the therapeutic goods are presented for supply, and includes matters relating to
the name of the goods, the labelling and packaging of the goods, and any advertising or other
informational material associated with the goods.
Practice Guidelines2
The Guidelines for Good Clinical Practice, as in force from time to time, published jointly by the
International Conference on Harmonisation on Technical Requirements for Registration of
Pharmaceuticals for Human Use and the Committee for Medicinal Products. (Regulation
12AB(2)(a)).
Primary pack1
The complete pack in which the goods, or the goods and their container, are to be supplied to
consumers.
Principal investigator2, 3
In relation to a clinical trial of therapeutic goods, the person who is in charge of the conduct of the
trial.
Principal manufacturer
The manufacturer who manufactures the goods or who performs one or more steps in the
manufacture of the goods and also contracts with, or controls the use of other sub-manufacturers
for the performance of the remaining steps in manufacture of the goods. (Note: manufacturers
listed in the Australian Register of Therapeutic Goods may not always fulfil this definition.)
Principal Regulations3
The Therapeutic Goods Regulations 1990.
Problem report
Report of a suspected deficiency of quality, safety or efficacy in a therapeutic good.
Product
The commercial presentation or marketed entity of therapeutic goods, excluding pack size. Where a
therapeutic device, it excludes such fine details as size or gauge; and, where a kit / tray or pack
containing one or more medicines, it is an individual medicine entity within the kit.
Product information
Information relating to the safe and effective use of the goods, including information regarding the
usefulness and limitations of the goods. (Section 9D(5)) Also referred to as PI. (Note that PI is used
also as an abbreviation for proprietary ingredient.)
Product material
This term is used in Australian Register of Therapeutic Goods (ARTG) application forms and guides
when asking for copies of information provided about the goods for medical practitioners and / or
patients / users. It includes Consumer Medicine Information (CMI), Product Information (PI) and
promotional material. Other information about the product required by ARTG applications includes
labels, information shown on packaging, and package inserts. For devices, it may also include
operating and service manuals. The ARTG computer system codes the information held in hard
copy by Therapeutic Goods Administration.
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Product name - medicines
The proprietary name as shown on the label or where there is no proprietary name, the
Registration / Listing name.
Product number
Reference number assigned by Australian Register of Therapeutic Goods to each product grouped
under one Registration or Listing.
Prohibited representation2
A representation referred to in Subregulation 8(1) of the Therapeutic Goods Regulations 1990.
Proprietary ingredient
Formulated ingredients, usually commercially obtained, for which the formulation may not be
available to the sponsor of the final product. Examples are perfumes and flavourings. Some active
ingredients may be supplied as proprietary ingredients. Also referred to as PI. (Note that PI is used
also as an abbreviation for product information.)
Proprietary name
The Registered trademark of the therapeutic goods or the unique name assigned to the goods by
the sponsor and appearing on the label.
Protected information1
Information is protected if it was given to the Secretary in relation to an application to Register a
therapeutic good and it relates to the active component of the therapeutic goods. It applies only to
active components which are new (not previously included in the Australian Register of
Therapeutic Goods) and if the goods became Registered after the commencement of subsection 25A
of the Therapeutic Goods Act 1989. Protected information lasts for five years after the Registration
of the product unless the person to whom the new goods are Registered provides the Secretary
permission in writing for the Secretary to use the information.
Public submission2
A submission under Regulation 42CT by a person who is not a Committee member.
Publisher
A person whose business it is to publish or insert, or to arrange for the publication or insertion of,
advertisements in any publication. (Section 42B)
Publishing
In relation to an advertisement, includes inserting material within the pages of an item of
mainstream media.
Quality1
Includes the composition, strength, potency, stability, sterility, purity, bioburden, design,
construction and performance characteristics of the goods.
Quarter2
A period of three months commencing on 1 January, 1 April, 1 July or 1 October in a year.
Recall
The permanent removal of therapeutic goods from supply or use for reasons relating to deficiencies
in the quality, safety or efficacy of the goods.
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Recall for product correction
The repair, modification, adjustment or relabelling of therapeutic goods for reasons relating to
deficiencies in the quality, safety or efficacy of the goods.
Record of ARTG entry
Refer S32(1) re copy of entry. A print out of the information about a product that has been entered
in the Australian Register of Therapeutic Goods database.
Register1
The Australian Register of Therapeutic Goods (ARTG) maintained under Section 9A of the
Therapeutic Goods Act 1989.
Registered goods1
Therapeutic goods included in the part of the Australian Register of Therapeutic Goods for goods
known as Registered goods.
Registrable goods
Goods that are required under Part 3 of the Therapeutic Goods Act 1989 and specified in Schedule 3
of the Therapeutic Goods Regulations 1990 to be included in that part of the Australian Register of
Therapeutic Goods for Registered goods.
Registration / Listing name - medicines
The name which will appear on the Certificate of Registration / Listing. The Registration / Listing
name is a fully descriptive name which enables clear identification of the goods as they are
presented for supply.
Where goods have a name that applies to more than one product, the name must be followed by
sufficient details to enable unique identification. That include:

the proprietary name (if any);

the non-proprietary name; or

a descriptive name that includes a commercial identifier such as the sponsor’s name; and must
include the dosage form and, where appropriate, the strength and container type.
Registration number1
Any combination of numbers, symbols and letters assigned to therapeutic goods under Section 27
of the Therapeutic Goods Act 1989. When printed on a label the Registration number must be
positioned in accordance with the requirements of Regulation 15 of the Therapeutic Goods
Regulations 1990 and preceded by ‘AUST R’.
Relevant test2
In relation to the analysis of therapeutic goods (other than medical devices), means a test that,
under Subregulation 28(1) of the Therapeutic Goods Regulations 1990, is a relevant test for the
purpose of determining whether goods of a class in which the first-mentioned goods are included
are goods that conform with a standard applicable to the goods. (Regulation 23)
Required representation2
A representation referred to in Subregulation 8(2) of the Therapeutic Goods Regulations 1990.
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Responsible analyst2
In relation to the analysis of a sample of therapeutic goods, means an official analyst who is
nominated as a responsible analyst for the sample under paragraph 25(3)(c) of the Therapeutic
Goods Regulations 1990. (Regulation 23)
Restricted goods1*
Medicines (including progesterone antagonists and vaccines against human chorionic
gonadotrophin) intended for use in women as abortifacients.
Restricted representation2
A representation referred to in subregulation 7A(1) of the Therapeutic Goods Regulations 1990.
Reviewable decision1
Refers to decisions of the Minister (or delegate) about reviews of initial decisions.
(Section 60 and Regulation 48)
Route of administration
Route by which a therapeutic good is applied on or introduced into the body.
Sample2
Includes part of a sample.
Samples officer2
An officer of the Department performing duties under the direction of an official analyst.
(Regulation 23)
Schedule 10 medicines
A medicinal product of a type described in Schedule 10 of the Therapeutic Goods Regulations 1990
as requiring evaluation by the Office of Medicines Authorisation.
Scheduling1
In relation to a substance, means determining the schedule or schedules to the current Poisons
Standard in which the name or a description of the substance is to be included. (Section 52A)
Scheduling meeting2
A meeting of the National Drugs and Poisons Schedule Committee for the scheduling of a substance.
(Regulation 42ZCT)
Secretary1
The Secretary of the Department.
Seize1
Includes secure against interference. (Section 45A)
Serious2, 3
In relation to a form of a disease, condition, ailment or defect, means a form of the disease,
condition, ailment or defect that is:
a.
b.
generally accepted as not being appropriate to be diagnosed or treated without consulting a
suitably qualified healthcare professional; OR
generally accepted to be beyond the ability of the average person to evaluate accurately, or
treat safely, without regular supervision by a suitably qualified healthcare professional.
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Service goods
Therapeutic goods that are required in the public interest but whose supply does not offer financial
incentive for the sponsor.
Single step of manufacture
For the purpose of annual licence charge classification only. For example, one of the following:
tablet coating; capsule filling from bulk; aerosol filling from bulk; storage other than for sale;
packaging including labelling; sterilisation; testing including analysis; releasing for sale (by a
person not involved with actually preparing the goods).
Site identification
Identification code assigned by the Office of Manufacturing Quality to a manufacturing site(s) for an
enterprise that is involved with the manufacture of therapeutic goods.
Specialist2
Has the same meaning as in the Health Insurance Act 1973.
Specified media2
In relation to an advertisement or generic information, means:
a.
mainstream media within the meaning of Section 42B of the Act; OR
b.
cinematograph films; OR
c.
displays about goods, including posters;
i.
ii.
iii.
in shopping malls (except inside an individual shop);
in or on public transport; or
on billboards.
Sponsor1, 3
A person who exports, imports or manufactures a therapeutic good, or who arranges the
exportation, importation or manufacture of the goods for supply. It does not include a person who
exports, imports or manufactures the goods or arranges the exportation, importation or
manufacture of the goods on behalf of another person who, at the time of the exportation,
importation, manufacture or arrangements, is a resident of, or is carrying on business in Australia.
Standard1
Matters specified in an order determined by the Minister and published in the Gazette. Must be
specified in a Therapeutic Goods Order or an approved pharmacopeia (British Pharmacopoeia,
European Pharmacopoeia and United States Pharmacopoeia). A general standard applies to all
products of a particular dosage form. A specific standard for drugs refers to a particular dosage
form of a particular active ingredient(s). (Section 10)
Standard AS / NZS2
A joint Australian and New Zealand Standard published by Standards Australia International
Limited and the body known as Standards New Zealand.
State
A State of the Commonwealth. The term also covers the Australian Capital Territory and the
Northern Territory.
State law1
A law of a State, of the Australian Capital Territory or of the Northern Territory.
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V4.2 August 2011
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Step in manufacture
Any part of the process of bringing goods to their final state and which may be completed
separately from other parts of the process.
Strength
The quantity of an ingredient in a drug or a formulated or medicated device expressed:

for discrete units, as the nominal weight of the ingredient in the unit

for other dosage forms, as the nominal weight or volume per unit weight or volume.
Sub-manufacturer
A manufacturer who completes part of the manufacturing process of therapeutic goods on behalf of
the principal manufacturer (no longer used in the Australian Register of Therapeutic Goods.
Replaced by manufacturer with an identified step in manufacture).
Submission
A series of related applications (as defined) made under Section 23 of the Therapeutic Goods Act
1989 on the same day and under the same covering letter.
Substance
Any medicine or poison. (Section 52A)
Supply1
Includes supply by way of sale, exchange, gift, lease, loan, hire or hire purchase. It also includes
whether free of charge or otherwise, samples or advertisements, supply for testing the safety or
efficacy, and for treatment of person or animal.
Tamper1
Therapeutic goods are tampered with if they are interfered with in a way that affects, or could
affect, the quality, safety or efficacy of the goods, and the interference has the potential to cause, or
is done for the purpose of causing, injury or harm to any person.
TGA Identification Number (TGAIN)
Number assigned by the Trans Tasman and Business Management Group (TTBMG) (formerly the
Trans Tasman Group (TTG) and the Business Management Unit (BMU)) to each transaction or
event. Proposed to become the core element in TGA tracking systems.
The Act2
The Therapeutic Goods Act 1989.
Therapeutic medicine - device combination
A therapeutic good in which the presentation of the medicinal product(s) includes therapeutic
device(s). These goods are classified as medicines for Registration / Listing in the Australian
Register of Therapeutic Goods (ARTG) but details of both the medicine and device component are
required for inclusion in the ARTG.
Therapeutic goods1
Goods:
a.
that are represented in any way to be, or that are, whether because of the way in which the
goods are presented or for any reason, likely to be taken to be:
i.
for therapeutic use; OR
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V4.2 August 2011
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ii.
iii.
b.
for use as an ingredient or component in the manufacture of therapeutic goods; OR
for use in a container or part of a container for goods of the kind referred to in
subparagraph (ii) or (iii); OR
that are included in a class of goods the sole or principal use of which is, or ordinarily is, a
therapeutic use or a use of a kind referred to in subparagraph (a)(ii) or (iii)
and includes medical devices and goods declared to be therapeutic goods under an order in
force under Section 7, but does not include:
c.
goods declared not to be therapeutic goods under an order in force under Section 7; OR
d.
goods in respect of which such an order is in force, being an order that declares the goods are
not therapeutic goods when used, advertised, or presented for supply in the way specified in
the order where the goods are used, advertised, or presented for supply in that way; OR
e.
goods for which there is a prescribed standard in the Australia New Zealand Food Standards
Code as defined under subsection 3(1) of the Food Standards Australia New Zealand Act 1991;
OR
f.
goods which, in Australia or New Zealand, have a tradition of use as foods for humans in the
form in which they are presented.
Therapeutic Goods Advertising Code1, 2
The Code known as the Therapeutic Goods Advertising Code notified in the Gazette with effect from
the date of commencement of Schedule 1 to the Therapeutic Goods Amendment Act (No 1) 2003
together with any amendments of the Code published by the Minister in the Gazette from time to
time.
Therapeutic goods information1
Information in relation to therapeutic goods that came into the possession of the Department in
connection with the performance of the Department’s functions (including functions relating to the
European Community (EC) Mutual Recognition Agreement or the European Free Trade Association
(EFTA) Mutual Recognition Agreement). (Section 61)
Therapeutic Goods Order (TGO)
A document published in the Gazette that specifies a standard for therapeutic goods or a class of
therapeutic goods identified in the order. Sponsors should refer to the Publications page on the
website for information about current TGOs.
Therapeutic use1, 2
Use in or in connection with:
a.
preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons or
animals; OR
b.
influencing, inhibiting or modifying a physiological process in persons or animals; OR
c.
testing the susceptibility of persons or animals to a disease or ailment; OR
d.
influencing, controlling or preventing conception in persons; OR
e.
testing for pregnancy in persons; OR
f.
the replacement or modification of parts of the anatomy in persons or animals.
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V4.2 August 2011
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Topical
Applied to a certain area of the skin for a localised effect.
Transdermal
Applied to the skin for a systemic effect by the diffusion or continuous absorption of the active
ingredient through the skin.
Trade name2
The commercial name given to goods of that kind by the manufacturer and under which the goods
are supplied.
Trading corporation1
A trading corporation within the meaning of paragraph 51(xx) of the Constitution.
Traditional use
Use of a designated active ingredient that is well-documented, or otherwise established, according
to the accumulated experience of many traditional healthcare practitioners over an extended
period; and accords with well-established procedures of preparation, application and dosage.
Visual broadcast media
Broadcast media that is intended to be viewed by its audience. (Section 42B)
Withdraw2
In relation to an approved advertisement, includes withdrawal by any delegate under
subregulation 5Q(2) or (3) of the Therapeutic Goods Regulations 1990, whether or not that
delegate gave the approval and, in the case of an approval given by the National Food Authority of
Australia (NFAA), includes a withdrawal by the Complementary Healthcare Council of Australia.
Australian Regulatory Guidelines for Complementary Medicines,
Part IV, Section 21 – Glossary of terms used in the ARGCM
V4.2 August 2011
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22. Abbreviations and
acronyms used in the
Australian Regulatory
Guidelines for
Complementary Medicines
AAN
Australian Approved (chemical substance) Name
AAT
Administrative Appeals Tribunal
ABN
Australian (approved) Biological substance Name
ACCM
Advisory Committee on Complementary Medicines
ACNM
Advisory Committee on Non prescription Medicines
ADR
adverse drug reaction
AFN
Australian (approved) Food Name
AGRD
Australian Guidelines for the Registration of Drugs (replaced by ARGCM,
ARGOM and / or ARGPM)
AHN
Australian (approved) Herbal Name
AHS
Australian (approved) Herbal Substance
ALT
alanine aminotransferase
AOAC
Association of Official Analytical Chemists (International)
ARGCM
Australian Regulatory Guidelines for Complementary Medicines
ARGOM
Australian Regulatory Guidelines for Over-the-Counter Medicines
ARGPM
Australian Regulatory Guidelines for Prescription Medicines
ARTG
Australian Register of Therapeutic Goods (the Register)
ASMI
The Australian Self-Medication Industry Incorporated
AQIS
Australian Quarantine Inspection Service
AUC
area under the curve
AUST L
Australian Listing Number (for Listed medicines)
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V4.2 August 2011
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AUST R
Australian Registration Number (for Registered medicines)
BP
British Pharmacopoeia
CAS
Chemical Abstracts Service (Registry)
CHC
The Complementary Healthcare Council of Australia
CD
compact disc
CHMP
Committee for Medicinal Products for Human Use (previously CPMP)
CIOMS
Council for International Organizations of Medical Sciences
CIR
Cosmetic Ingredient Review (Group) of the USA
CITES
Convention on International Trade in Endangered Species (of Wild Fauna and
Flora)
Cmax
Maximal blood concentration
CMI
Consumer Medicine Information
C(PI) Regs.
Customs (Prohibited Import) Regulations
CPMP
Committee for Proprietary Medicinal Products (of the EMEA)
CTD
Common Technical Document
CTFA
Cosmetic, Toiletry and Fragrance Association (USA)
CTN
Clinical Trial Notification scheme
CTX
Clinical Trial Exemption scheme
DNA
deoxyribonucleic acid
EC
European Commission
ECD
electrochemical detection
EEC
European Economic Community
EFTA
European Free Trade Area
ELF 3
Electronic Listing Facility – Version 3
EMEA
European Medicines Agency (previously European Agency for the Evaluation of
Medicinal Products)
EPA
Environmental Protection Agency (of the United States of America)
EP
European Pharmacopoeia (also known as PH. Eur.)
EU
European Union
EudraLex
The Rules Governing Medicinal Products in the European Union
FAO
Food and Agriculture Organization (of the United Nations)
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Section 21– Abbreviations and acronyms used in the ARGCM
V4.2 August 2011
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FDA
Food and Drug Administration (of the United States of America)
FEMA
Flavour and Extract Manufacturers Association (of the United States of
America)
FOI
Freedom of Information
FSANZ
Food Standards Australia and New Zealand
FSTA
Food Science and Technology Abstracts
GC
gas chromatograph(y)
GCP
good clinical practice
GLP
good laboratory practice
GM
genetically modified
GMO(s)
genetically modified organism(s)
GMP
good manufacturing practice
GRAS
generally regarded as safe
HACCP
Hazard Analysis Critical Control Points
HCN
(Australian approved) Herbal Component Name
HDL
high-density lipoprotein
HDPE
high-density polyethylene
HPLC
high-performance liquid chromatography
HREC
Human Research Ethics Committee
HSDB
Hazardous Substances Databank
IBIDS
International Bibliographic Information on Dietary Supplements
ICH
International Conference on Harmonisation (of Technical Requirements for
Registration of Pharmaceuticals for Human Use)
IV
intravenous
LCS
Listing Compliance Section (of the OCM)
LD50
The dose required that is lethal for 50 per cent of the animal study group
LDL
low-density lipoprotein
LDPE
low-density polyethylene
MRA
Mutual Recognition Agreement
MS
mass spectrometry
NICNAS
National Industrial Chemicals Notification and Assessment Scheme
NOAEL
no observable adverse effect level
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V4.2 August 2011
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NHMRC
National Health and Medical Research Council
NMT
not more than
OCM
Office of Complementary Medicines
ODBT
Office of Blood, Devices and Tissues
OECD
Organisation for Economic Co-operation and Development (International)
OTC
over-the-counter
PBS
Pharmaceutical Benefits Scheme
PCBs
polychlorinated biphenyls
PDF
portable document format
pH
Negative logarithm of hydrogen-ion concentration
PH Eur
European Pharmacopoeia (also known as EP)
PI
product information
PI
proprietary ingredient
PO
(per os) oral administration
PPM
parts per million
PRCP
People’s Republic of China Pharmacopoeia
PREMAS
Pre-Market Assessment Section (of the OCM)
PRV
provisional
PVC
polyvinyl chloride
PVDC
polyvinylidene chloride
QA
quality assurance
qs
(quantum satis) sufficient quantity
RCT
randomised controlled trial
RH
relative humidity
RTECS
Register of Toxic Effects of Chemical Substances
SUSMP
Standard for the Uniform Scheduling of Medicines and Poisons
TEP
tamper-evident packaging
TGA
Therapeutic Goods Administration
TGAC
Therapeutic Goods Advertising Code
TGACC
Therapeutic Goods Advertising Code Council
TGAIN
TGA Identification Number
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Section 21– Abbreviations and acronyms used in the ARGCM
V4.2 August 2011
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TGO
Therapeutic Goods Order
TLC
thin-layer chromatography
Tmax
Time to maximal blood concentration
TSE
transmissible spongiform encephalopathy
URPTG
Uniform Recall Procedure for Therapeutic Goods
USP
United States Pharmacopoeia
USP-NF
United States Pharmacopoeia – The National Formulary
UDS
unscheduled DNA synthesis
US FDA
Food and Drug Administration (of the United States of America)
UV
ultraviolet
VLDL
very low density lipoprotein
WHO
World Health Organization
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Therapeutic Goods Administration
23. Hyperlink references
contained in the Australian
Regulatory Guidelines for
Complementary Medicines
This section is divided into the following subsections:
23.1.
Therapeutic Goods Act 1989
23.2.
Therapeutic Goods Regulations 1990
23.3.
TGA guidance
23.4.
Other guidance
23.5.
Forms
23.6.
Therapeutic Goods Orders
23.7.
Other legislation
23.8.
E-mail contacts
23.9.
Other regulatory agencies
23.10. Miscellaneous
Links to external documents (hyperlinks) have been electronically inserted into the Australian
Regulatory Guidelines for Complementary Medicines (ARGCM) text for the ease of sponsors seeking
additional guidance (who read/refer to the ARGCM documents electronically / on-line).
In order to provide the same level of assistance to sponsors referencing the hard (printed) copy of
the ARGCM, a list of hyperlinks has been compiled and is included below.
A list of European Union (EU) Guidelines referenced in the ARGCM is included in Section 5 of Part V.
Accordingly, EU Guidelines have not been included in the list below.
Note: While every effort will be made to keep this list up-to-date, the OCM cannot
ensure the integrity of these hyperlinks (particularly to those on the AttorneyGeneral’s Department website, SCALEplus).
Australian Regulatory Guidelines for Complementary Medicines, Part IV,
Section 22 – Hyperlink references contained in the ARGCM
V4.2 August 2011
Page 98 of 106
Therapeutic Goods Administration
23.1.Therapeutic Goods Act 1989
Document Link Name
Therapeutic Goods Act 1989
Internet Address
http://www.comlaw.gov.au/Series/C2004A03952
23.2.Therapeutic Goods Regulations 1990
Document Link Name
Internet Address
Therapeutic Goods Regulations 1990
http://www.comlaw.gov.au/Series/F1996B00406
23.3.TGA guidance
Document Link Name
Internet Address
Access to Unapproved Therapeutic
Goods – Clinical Trials in Australia
http://www.tga.gov.au/industry/clinical-trialsguidelines.htm
Advertising Therapeutic Goods –
Restricted Representations
http://www.tga.gov.au/industry/advertising-restrictedrepresentations.htm
Regulatory system for Medical devices
http://www.tga.gov.au/industry/devices.htm
Australian Approved Terminology
for Medicines
http://www.tga.gov.au/industry/medicines-approvedterminology.htm
Australian Code of Good
Manufacturing Practice for Medicinal
Products
http://www.tga.gov.au/industry/manuf-medicinescgmp.htm
Australian Pharmacovigilance
Guideline
http://www.tga.gov.au/safety/australianpharmacovigilance-guideline.htm
Australian Regulatory Guidelines for
OTC Medicines (ARGOM)
http://www.tga.gov.au/industry/otc-argom.htm
Australian Regulatory Guidelines for
Prescription Medicines (ARGPM)
http://www.tga.gov.au/industry/pm-argpm.htm
Colourings Permitted in Medicines for
Oral Use
http://www.tga.gov.au/industry/pm-argpm-guidance22.htm
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Section 22 – Hyperlink references contained in the ARGCM
V4.2 August 2011
Page 99 of 106
Therapeutic Goods Administration
Document Link Name
Internet Address
Cosmetic Claims Guidelines – May
1997
http://www.nicnas.gov.au/Current_Issues/Cosmetics.asp
ELF 3 User Guide
http://www.tga.gov.au/about/ebs-elf-userguide.htm.
EU Guidelines adopted by the TGA
http://www.tga.gov.au/industry/pm-euguidelinesadopted.htm
Exporting Medicines from Australia –
Operational Guidelines
http://www.tga.gov.au/industry/export-medicinesguidelines.htm
Guidance for GMP clearance for
Overseas Manufacturers
http://www.tga.gov.au/industry/manuf-overseasmedicines-gmp-clearance.htm
Guidelines for Levels and Kinds of
Evidence to Support Indications and
Claims
http://www.tga.gov.au/industry/cm-evidence-claims.htm
Literature Based Submissions – Points
to Consider
http://www.tga.gov.au/industry/pm-literature-basedsubmissions.htm
Guidance on Product Changes in ELF
3
http://www.tga.gov.au/about/ebs-elf-productchanges.htm
Questions & Answers for the
Identification of Herbal Materials and
Extracts
http://www.tga.gov.au/industry/cm-identificationherbal-extracts.htm
Questions & Answers on the Stability
Testing of Listed Complementary
Medicines
http://www.tga.gov.au/industry/cm-stability-testingqa.htm
Quantified By Input
http://www.tga.gov.au/archive/cm-qbi.htm
Reporting Problems with Medicines
http://www.tga.gov.au/safety/problem.htm
Substances that may be used as
active ingredients in 'Listed'
medicines in Australia
http://www.tga.gov.au/industry/cm-listedsubstances.htm
Summary Classification of Medicines
http://www.tga.gov.au/industry/basics-medicinesclassification.htm
Supplementary Requirements for
Therapeutic Goods for Minimising the
Risk of TSEs
http://www.tga.gov.au/industry/tse-supplementaryrequirements.htm
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V4.2 August 2011
Page 100 of 106
Therapeutic Goods Administration
Document Link Name
Internet Address
Tamper-Evident Packaging Guideline
http://www.tga.gov.au/industry/packaging-tamperevident-guideline.htm
TGA Guidelines for Sterility Testing
of Therapeutic Goods
http://www.tga.gov.au/industry/manuf-sterility-testingguidelines.htm
Therapeutic Goods Order 77 –
Microbiological standards for
medicines (TGO 77)
http://www.comlaw.gov.au/Details/F2008L03574
Therapeutic Goods Administration
(TGA) Policy for the Export of
Medicines from Australia
http://www.tga.gov.au/industry/export-medicinespolicy.htm
Uniform Recall Procedure for
Therapeutic Goods
http://www.tga.gov.au/safety/recalls-urptg.htm
23.4.Other guidance
Document Link Name
Internet Address
Chemical Abstracts Service (CAS)
Registry
http://www.cas.org/
Guidance for Industry –
Bioavailability and Bioequivalence
Studies for Orally Administered Drug
Products – General Considerations
FDA (Revision 1 – March 2003)
http://www.fda.gov/cder/guidance/5356fnl.pdf
National Statement on Ethical
Conduct in Research Involving
Humans, NHMRC, 1999
http://www.nhmrc.gov.au/publications/synopses/e35sy
n.htm
Standard for the Uniform Scheduling
of Drugs and Poisons (SUSMP)
http://www.tga.gov.au/industry/scheduling-poisonsstandard.htm
Therapeutic Goods Advertising Code
(TGAC)
http://www.tgacc.com.au/codeList.cfm
Appendix 6 of the TGAC
http://www.tgacc.com.au/code.cfm?sectionheading=APP
ENDIX%206
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V4.2 August 2011
Page 101 of 106
Therapeutic Goods Administration
23.5.Forms
Document Link Name
Internet Address
Application form for proposing a
chemical name (AAN or ADN and
chemical PRV)
http://www.tga.gov.au/industry/medicines-approvedterminology.htm#forms
Application form for proposing a
biological name (ABN and biological
PRV) or term
http://www.tga.gov.au/industry/medicines-approvedterminology.htm#forms
Application form for proposing a
botanical name for a herb (AHN and
herbal PRV)
http://www.tga.gov.au/industry/medicines-approvedterminology.htm#forms
Application form for proposing a
herbal substance name (AHS and
herbal substance PRV)
http://www.tga.gov.au/industry/medicines-approvedterminology.htm#forms
Application form for proposing a
herbal component name (HCN)
http://www.tga.gov.au/industry/medicines-approvedterminology.htm#forms
Application form for proposing a
Label-AAN (for all name types)
http://www.tga.gov.au/industry/medicines-approvedterminology.htm#forms
Application form for proposing
approved name(s) be added to a
Label-AAN group (all name types)
http://www.tga.gov.au/industry/medicines-approvedterminology.htm#forms
Registered (Complementary)
Medicine Variation Form
http://www.tga.gov.au/industry/cm-forms-registeredvariation.htm
eBS Client Details Form
https://www.ebs.tga.gov.au/
eBS e-business Document
https://www.ebs.tga.gov.au/
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V4.2 August 2011
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Therapeutic Goods Administration
23.6.Therapeutic Goods Orders
Document Link Name
Internet Address
Current TGOs
http://www.tga.gov.au/industry/legislation-tgo.htm
TGO 78 – Standard for tablets, and
capsules
http://www.comlaw.gov.au/Details/F2008L04287
TGO 80 – Child-Resistant Packaging
for Therapeutic Goods
http://www.comlaw.gov.au/Details/F2008L03428
TGO 69 – General requirements for
labels for medicines
incl. TGO 69A, B, C – Amendments to
TGO 69
http://www.comlaw.gov.au/Details/F2009C00264
Code of Practice for Tamper-Evident
Packaging (TEP) of Therapeutic
Goods
http://www.tga.gov.au/industry/packaging-tamperevident-guideline.htm
TGO 77 – Microbiological standards
for medicines
http://www.comlaw.gov.au/Details/F2008L03574
TGO 70B – Standards for export only
medicine
http://www.comlaw.gov.au/Details/F2007L00555
23.7.Other legislation
Document Link Name
Internet Address
Customs Act 1901
http://www.comlaw.gov.au/Series/C2004A07371
Environment Protection and
Biodiversity Conservation Act 1999
http://www.comlaw.gov.au/Series/C2004A00485
Freedom of Information Act 1982
http://www.comlaw.gov.au/Details/C2011C00052
Gene Technology Act 2000
http://www.comlaw.gov.au/Series/C2004A00762
Therapeutic Goods (Medical Devices)
Regulations 2002
http://www.comlaw.gov.au/Series/F2002B00237
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V4.2 August 2011
Page 103 of 106
Therapeutic Goods Administration
23.8.E-mail contacts
Document Link Name
Internet Address
TGA Office of Medicines Safety
Monitoring
adr.reports@tga.gov.au
Report an event (electronically)
https://www.ebs.tga.gov.au/ebs/ADRS/ADRSRepo.nsf?O
penDatabase
eBS Help Desk
eBs@tga.gov.au
TGA Information Officer (e-mail)
info@tga.gov.au
Office of Complementary Medicines
ocm@tga.gov.au
TGA Office of Medicines Safety
Monitoring
adr.reports@tga.gov.au
Report an event (electronically)
https://www.ebs.tga.gov.au/ebs/ADRS/ADRSRepo.nsf?O
penDatabase
23.9 Other regulatory agencies
Document Link Name
Internet Address
European Medicines Agency (EMEA)
http://www.emea.europa.eu/
US Food and Drug Administration
(US FDA)
http://www.fda.gov
23.10.
Miscellaneous
Document Link Name
Internet Address
Code of Practice for Ensuring Raw
Material Quality & Safety
(Complementary Healthcare Council
of Australia)
http://www.chc.org.au/AboutUs/CodeofPractice/
National Industrial Chemicals
Notification and Assessment Scheme
(NICNAS)
http://www.nicnas.gov.au/
Australian Regulatory Guidelines for Complementary Medicines, Part IV,
Section 22 – Hyperlink references contained in the ARGCM
V4.2 August 2011
Page 104 of 106
Therapeutic Goods Administration
Document Link Name
Internet Address
Oxford Centre for Evidence-Based
Medicine (CEMB)-
http://www.cebm.net/cebm.net/
TGA eBusiness Services home page
https://www.ebs.tga.gov.au/
Summary of TGA Fees and Charges
http://www.tga.gov.au/about/fees.htm
Australian Regulatory Guidelines for Complementary Medicines, Part IV,
Section 22 – Hyperlink references contained in the ARGCM
V4.2 August 2011
Page 105 of 106
Therapeutic Goods Administration
PO Box 100 Woden ACT 2606 Australia
Email: info@tga.gov.au Phone: 02 6232 8444 Fax: 02 6232 8605
www.tga.gov.au
TRIM Reference R11/428602